Centchroman FAQ - Read This First! (Updated)

Discussion in 'Centchroman' started by KandC, Jul 12, 2006.


 
  1. KandC

    KandC New Member

    Repost of SusanT's FAQ from "Centrchoman Part 2", put here for obviousness. =)

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    This is the collaborative effort between GreenTea and SusanT from the Aphrodite forum. I have simply reformatted and updated it with some newer information for this board. Thank you, Susan and GreenTea!

    Please make comments, questions and amendments in a new post, and a moderator will update this post as required.

    What is Centchroman?

    Non-steroidal (non-hormonal) contraceptive pill developed in India more than 20 years ago, and released to the public in India as a contraceptive medication over 10 years ago. It is marketed in India under two brand names, the most common of which (among users on this board) is Saheli. The other brand name is Centron.

    Click here to see basic information from the government-funded enterprise that developed Centchroman in India.

    Click here to see basic information from the company that markets Saheli.

    Click here to see what Johns Hopkins University has to say.

    If it's not a synthetic hormone, then what is it?

    Unlike traditional hormonal contraceptives, Centchroman does not introduce synthetic hormones and altered hormonal levels into your body. Instead, Centchroman is a Selective Estrogen Receptor Modulator (SERM). SERMs are compounds which influence the way that the body's own estrogen functions at various organs in the body, sometimes enhancing estrogen's effect, at other times hindering or limiting estrogen's effect, depending on the tissue. SERMs are used medically to treat breast lumps and cancer, osteoporosis after menopause, and other conditions. Centchroman is basically synonymous with an SERM called Ormeloxifene.

    To review an online slideshow about SERMs, and Ormeloxifene (centchroman) specifically, click here . Much of the content may be scientific in nature, but you should get the general message from a few summary slides in particular. This slideshow was developed by a gynecological researcher in India and presented at a conference on gynecology and obstetrics in 2002.

    How does Centchroman work?

    In a normal menstrual cycle, the uterus and ovaries work in tandem: the uterus is ready for implantation at the time ovulation occurs and for several days after. In a woman taking Centchroman, the cycle becomes out of sync: ovulation happens sooner, and the uterine lining builds up more slowly. As a result, when the egg or zygote reaches the uterus, the lining isn't built up enough for it to implant. It has also been speculated that Centchroman may make the zygote move faster through the fallopian tubes, which may also interfere with implantation.

    How effective is Centchroman as birth control?

    Clinical trial users who took the dosing currently recommended, and used back-up protection for the first two or three months, experienced a failure rate of less than 2%, which is fairly comparable to traditional birth control pills. Click here to see a brief summary of the company's clinical effectiveness studies.

    How do we know it is safe to take?

    Clinical research on Centchroman took place in India from the 1960's through the 1980's, and it has been on the market there since the late 80's/early 90's. There have been no documented adverse effects to users, no reported complications from women who have used it for continuous years. Children born to mothers who were taking centchroman (and experienced a method or user failure) were followed for several years and displayed no developmental problems. Women who withdrew from the clinical trials to become pregnant conceived within the expected amount of time for people of normal fertility who are not using contraception: all but one or two (out of thirty-some) within a year, more than half of those within six months. Only one did not become pregnant, and she was 39 years old with five living children.

    The research that has been conducted in India to document its safety and effectiveness is at least comparable to, probably in excess of, the research that first brought our familiar hormonal pill to the market.

    Does it have any side effects?

    The only clinically documented side effect is a delayed menstrual cycle. Most users will have lengthened and irregular cycles at least some of the time. For most, the cycle becomes regular again after the initial adjustment period, although it may be a slightly
    different schedule from before. As an example, I, GreenTea, had a fairly regular 4 to 4 1/2 week cycle when I wasn't taking anything, and now have a 4 1/2 to 5 week cycle. Some users on this board have experienced additional side effects, especially during the initial months of use, which often go away within a couple months or less, such as:

    - Period becomes heavy when first pill is taken
    - Initial period(s) on Saheli heavier, more painful, and/or
    stopping abruptly
    - Tender breasts
    - Water retention
    - Acne, usually minor
    - Shortened/oddly timed menstrual cycles, especially during
    early months
    - Hot flushes
    - Shorter/lighter periods

    Not all new users experienced these side effects. Some users were also transitioning off of hormonal birth control, thus their experiences may be complicated with symptoms of withdrawal from synthetic hormones (such as emotional symptoms). On Centchroman,
    cycles tend to eventually fall into a rhythm, especially once the dosage is changed from 2 pill/week to 1 pill/week (after the first three months). A very few number of users report having little to no period while on this pill.

    What does not happen with Centchroman is effects such as nausea, headache, weight gain, breakthrough bleeding, or mood problems, let alone anything fatal, as can happen with hormonal pills. Most of us who take Centchroman have had adverse reactions to hormones (which motivates us to try something different), but no ill effects from
    Centchroman.

    Is there anyone who should not take Centchroman?

    Women who have PCOS, or have chronic cervicitis or cervical hyperplasia should not take it, according to the package insert that comes with Saheli as it is packaged for sale in India. The insert also lists 'severe allergic conditions,' 'chronic illnesses like tuberculosis, renal disease,' and 'recent or past history of jaundice or liver disease' as contraindications. To see a discussion on the MSN Centchroman Club that clarifies this a bit, click here . The new package insert states that Centchroman is safe for lactating women.

    On the Aphrodite message board, it was discussed that PCOS is only contraindicated for Centchroman use due to women with is being excluded from the initial clinical trials. This was a decision made by the initial researchers as it might be impossible to distinguish between side-effects from the drug and from the disease. There is no evidence that Centchroman would cause or exacerbate PCOS or ovarian cysts. See the post by greengrl here , the fifth post from the top.

    The current users among us include two women with histories of severe allergic reactions to many things, and one or two who had hepatitis A in childhood but no liver problems since--so, if you have a condition that you think might be a contraindication, but aren't 100% sure, you are quite welcome to post in the discussion groups and ask--it may or may not be.

    How do I obtain Centchroman? How much does it cost?

    Because Centchroman is only available in India at the present time, users from other countries must order it from online pharmacies based in India. One popular choice is All Day Chemist at http://www.alldaychemist.com/ which accepts online payments. It may take 2-3 weeks to arrive. Pills are good for about 2 years after the date of manufacturing, thus can be ordered in a batch for a year or more. Centchroman is sold over the counter in India (as are all birth control pills), so there is no requirement for a prescription, and no legal restriction on how much they can sell to an individual customer.

    Laws in India prevent companies from selling drugs at prices in great excess of their cost. Thus, centchroman is not very expensive (especially given the exchange rate with our currencies). Most of the cost is in the shipping and handling. All Day Chemist does mark up their shipping costs substantially, but the overall cost is still very reasonable. A 12-14 month supply should cost in the neighborhood of $50 USD.

    We are also aware of another online pharmacy that lists Centchroman. It can be found at http://www.avoidmiddleman.com/ . So far, no one who posts here has said that they'd ordered from this site or knew much about it, but it is also a possible source. Anyone who finds additional sources is more than welcome to post them in this forum. If you are concerned about the reliability of the source, the best way to find out is from people who have used it. At least two dozen of us have used All Day Chemist and found them to be reliable, and to send what they say they're sending. To check the reputation of any online pharmacy, this site is helpful: http://www.overseaspharmacy.com/phpBB/ . It's set up specifically for internet pharmacy customers to discuss their experiences with particular pharmacies.

    How do I take Centchroman?

    Centchroman is touted as a 'weekly' oral contraceptive. However, for the first twelve weeks it is advised to take the pill twice per week. From the thirteenth week on, it is taken once per week.

    Backup protection (that is, barrier methods if you are sexually active) has been advised in most discussions on the internet, but the manufacturer does not give clear direction as to how long. Advice on various boards was to use backup methods for the first two months, or even the first three months if you wanted to be super safe. This appears to be an unfounded recommendation, based on the failures in the initial studies before the above dosing regime was decided upon. According to a consultant doctor to HindaLatex (one of the companies marketing Centchroman in India), as long as all pills are taken in
    the first 2 weeks, no backup protection is necessary. See the 7th post by sarahbear here .

    Consensus now appears that backup protection in the first month is a cautious but sensible move.

    When initially starting, the first pill is taken on the first day of a period, and the second pill three days later. This pattern of days is repeated through the first twelve weeks. For example, Monday- Thursday, Tuesday-Friday, Wednesday-Saturday, Thursday-Sunday, Friday- Monday, Saturday-Tuesday. Starting the thirteenth week, the weekly pill is taken on the first pill day. Continued use will not match up with the menstrual cycle (unlike the hormonal contraceptive pill) and you continue to take the pill on the weekly schedule regardless of when your subsequent periods arrive.

    Some limited additional research has suggested that slight variations on this schedule may be as effective, or possibly even more effective, but this is based on limited data. For more information, click here and the post by MukkaPizza here (the 9th post from the top).

    If for some reason you do not have a menstrual period (i.e. withdrawal from hormones, nursing, low body fat), keep in mind that Centchroman really must be started on the first day of your period. Since it works by altering the menstrual cycle, it may not be effective if it's not started at the beginning of one. If you are switching from hormonal birth control, starting Centchroman on your last withdrawal period is a possibility, although some users prefer to wait for a natural period.

    If this is as good as it sounds, why isn't it FDA-approved?

    The U.S. FDA only reviews research on, and subsequently approves, drugs which companies wish to bring to market. If no company in the U.S. feels it is profitable enough to obtain the patent for Centchroman, invest in research the FDA may require, and invest in the marketing (which would be substantial, for such a novel new
    drug), then the FDA does not get involved. Given that this pill is taken only once per week (after the initial three months), does not have side effects that would require additional drugs (such as antidepressants), and so many women are 'happily' taking hormonal contraception, its potential for profit may simply not be promising enough for any company to take it on. So, it is true that this is not an 'FDA-approved' drug.

    If this isn't available in my country (outside India), how can it be legal to use?

    In the United States, it is subject to the laws and regulations set forth by the FDA and by Customs, regarding its import into the country. Click here to read firsthand the FDA's compliance guidance from their Regulatory Procedures Manual, about the 'personal importation' policy and enforcement of the laws that effect importation of medications through both mail and baggage.

    To be honest, the importation of Centchroman into the U.S. is not technically legal. However, neither is driving even one mile over a posted speed limit. Enforcement of the laws is at the discretion of the FDA and Customs. The FDA itself has made it clear that strict enforcement of these laws, when there is clearly no substantial threat or concern involved, is not a priority.

    It IS possible that Customs could stop your package from India at the border, determine its contents to be illegal, and send you notification that you will not be getting your package. This is the extent of any legal consequence, and has only been known to happen once or twice. In those cases, the pharmacy resent the package, and it was received with no trouble. You need not worry about being arrested, fined, or otherwise punished.

    Outside the United States, it depends on the law in that particular country. Check your country's Customs website for laws and policies on importation of foreign medications for personal use. So far, Aphrodite members have imported Centchroman to Canada, Australia, and Britain, as well as the U.S., without any problems.

    How many women on Aphrodite are currently using Centchroman?

    Discussion about Centchroman first picked up on Aphrodite in September of 2005, when one member mentioned it, but there were no users. One American user (GreenTea) joined Aphrodite in November, and helped get the discussion going. Rather quickly, other members began using Centchroman. As of March 29, 2006, we estimate there are nearly two dozen users who frequent the Aphrodite discussion boards, and a few others actively considering it. The length of time these women have been using Centchroman ranges from having just started, to just under two years. We are all learning together as we go!

    OK, this sounds good Where can I go to hear more about the experiences of users, and read even more information in detail?

    http://www.hindlatex.com/TipsnGuidesdetails.aspx?valid=1&category=0&id=170&type=25 Information from the company that markets Centchroman, Hindustan Latex

    http://www.reproline.jhu.edu/english/1fp/1advances/old/1centch/ceorvw.htm Information From John Hopkins University

    http://www.hindlatex.com/TipsnGuidesdetails.aspx?valid=1&category=0&id=166&type=17 Clinical effectiveness studies

    http://www.obgyn.net/english/pubs/features/presentations/panda6/SERMs.ppt A slideshow on SERMs (selective estrogen receptor modulators)

    http://www.alldaychemist.com/ All Day Chemist, trusted supplier

    http://www.aphroditewomenshealth.com/ubb/ultimatebb.php?/topic/4/4.html The original Centchroman discussion on Aphrodite Women's Health

    http://www.aphroditewomenshealth.com/ubb/ultimatebb.php?/topic/4/5.html Aphrodite discussion, part 2

    http://centchroman.forumsplace.com/ A short-lived forum before Aphrodite was set up with a separate section. Some interesting posts, preserved for others to read

    http://groups.msn.com/Centchromanclub MSN Centchroman Club
    Last edited by a moderator: Aug 24, 2013

     
  2. RaeS

    RaeS New Member

    Wow, really great update, KandC!

     
  3. LilyDreams

    LilyDreams New Member

    Awesome summary, KandC!

    I sent Dr. NV an e-mail this morning asking if the patent for Centchroman was filed internationally and if so, if there were any US companies who had or were seeking a license from CDRI (Central Drug Research Institute, the goverment entity in India where it was developed) to develop it commercially in North America or any other foreign markets. I will let you know what she says. I'd be really curious to see if I could get to the heads of business development departments of major pharmaceutical companies in the Western world that market hormonal birth-control to find out if they ever considered developing non-hormonal birth control options or if they would ever consider developing this one (if licensing was possible) and if not, why? I found it curious that a lot of research is being done to develop both hormonal and non-hormonal birth control pharmaceuticals for use in men! While it is a great benefit to be able to get Centchroman from India at a minimal price, there's no denying the benefits that would be conferred by development in the US or Western world, outside of India. To name just one is that it would be more widely available to all those women out there who don't have an optimal birth control option and may be suffering from the use of hormonal birth control. Additionally, I plan to have a discussion with a gynecologist friend of mine about why SERMs (selective estrogen receptor modulator) the class of drug that centchroman falls under, have not been further studied and developed for their contraceptive effects. He has both the clinical background, as well as industry/FDA experience, so his response should be interesting. I'm feeling like a little bit of a crusader right now having just learned of this option and wanting everyone else to know about it, too!! Thanks again for consolidating this information in such a thorough fashion.

     
  4. MyrtleWarbler

    MyrtleWarbler Super Moderator Staff Member

    As a primary author on the original FAQ, I happily approve. Good work! I surely didn't have time for it recently. I think it would be useful to have this post pinned to the top with the others, since it has the nice title that would surely draw the attention of new readers. Perhaps GreenTea or another moderator would do this?

     
  5. Cami

    Cami New Member

    ta da!!! Its featured! You should see it at the top now becuase i agree...this should be pinned up there to grab newbiews attention

     
  6. MyrtleWarbler

    MyrtleWarbler Super Moderator Staff Member

    Quick UPDATE:

    Based on a tally from the "Roll Call" post, plus a few I know of who didn't post there (e.g., my neighbor, who is using it and liking it, but not posting actively), the total number of Saheli users on this forum is actually about THREE DOZEN now. And I bet we're missing a few people, those who only pop on now and then to say all is well. The ranks are growing quickly.

     
  7. SupaKat

    SupaKat Member

    I have a friend using it too Susan & she is not a poster here.

     
  8. GreenTea

    GreenTea Super Moderator Staff Member

    Wow! Thanks so much, KandC! And Cami, thanks for featuring it.

    I'm glad to see how this website moves forward all the time. It's great to come "back" after a busy week and see how many new topics there are.

     
  9. Res

    Res New Member

    ok, i have to try this. i just read almost every link and i'm totally convinced that it's the best option. i've been trying to find the right non-hormonal BC for a couple years. did you say it's only 50$ for a 12-14 month supply? just wanted to get that straight. yea yea yea!!!

     
  10. creads

    creads New Member

    well this is exciting. I am getting an paragard IUD put in and I have been reading in horror all of the women who were unhappy with this method. I will never use hormones again and I am encouraged but a little unsure about this Indian drug.

    It still affects your body's natural cycles, yes? How is that better than hormones? How reliable are these tests and this research that comes from a developing nation (no offense to India - it might be more reliable because their researchers aren't beholden to powerful drug companies).

     
  11. MyrtleWarbler

    MyrtleWarbler Super Moderator Staff Member

    Some women are quite happy on the Paragard, so if you're already on that path and basically feel fine about it, give it a try. Most women come here because they have had problems, so you read about them. I have two friends who had/have it - one is now on Saheli b/c it was hell for her, the other loves her IUD. Neither have had children before. You just never know.

    The primary difference between Saheli and hormonal birth control is that hormonal pills introduce synethic hormones intor your system, and basically trump your body's natural hormones completely. Pretty drastic. Saheli affects the way that your body's OWN estrogen functions at organs or tissues of interest, the uterus primarily.

    The research establishing the safety and effectiveness of Saheli are published and long-standing. India is "developing" in many ways, and well-developed in others (such as government-funded medical research). And you're right, this was not developed by a drug company, and laws there prevent the kind of sweeping profits such companies make here, so the motivations are indeed different.

     
  12. creads

    creads New Member

    Okay, I am reading more about this stuff on other websites and I like what I am seeing but I'd like to pose another question. I found this passage on one of the websites:

    "Contraceptive effects are related to slight acceleration of embryo transport through the oviducts and accelerated blastocyst formation along with suppression of uterine proliferation and decidualisation as well as alteration in biochemical parameters of implantation thus creating an asynchrony between embryo and uterine development, acritical requisite for nidation."

    Now, from what I understand of the language (not very user friendly, that), it's saying that a fertilized egg won't find a welcoming uterus and that the egg (embryo) will be rapidly expelled. So in affect causing mini-abortions. Don't get me wrong, I am not looking to start an abortion debate, but I want to be fully cognizant of what would be going on in my body.
    Another question I have is: If ovulation and uterine lining are made to asynchronistic, why aren't users having two periods? I mean - both would be expelled with some blood, right?

    Or perhaps I do not understand how this works...

    Help? Comments? Elucidation?
    Last edited by a moderator: Aug 24, 2013

     
  13. gds

    gds New Member

    Creads,

    As far as I know, a fertilised egg is not going to have blood when expelled if that happens at a different time to menstruation. The egg is a microscopic size, and doesn't have it's own blood.

    On your other question, yes you could argue that it is a 'mini abortion.' This has been covered in previous threads, but I will make a comment here. I am not of this belief. Over 80% of all fertilised eggs in humans _never_ implant anyway. So an argument could be made that simply having unprotected sex causes 'mini abortions,' even if trying to get pregnant. Of course most women would never know they had had a fertilised egg, and would just continue with their normal cycle.

    Any contraceptive method which does not prevent sperm and egg from meeting will has this effect. This includes Centchroman, in some cases the 'traditional' contraceptive pill, 'Plan B' and also IUD's. An IUD prevents a fertilised egg from implanting in the uterus due to it's presence in the uterus, and it gets passed out with menstruation instead.

    On a semi-separate issue, I find the use of the word 'abortion' unnecessarily imflammatory. It provokes images that are simply incorrect when talking about these topics.

    I am not wanting to preach. I do want to make sure an argument is consistent from all angles!

    I hope that makes sense...

    G

    (edited for formatting issues!)

     
  14. creads

    creads New Member

    First: I apologize. I didn't mean to be unnecessarily inflammatory. I should have simply said “the expelling of a potentially viable fertilized egg.”

    I was researching the paragard when I came across Centchroman and I am sorry if I've asked questions answered in different threads. I've been reading a lot of threads about Centchroman and I did not see it addressed. I appreciate that you took the time to answer it again.
    I didn’t realize that the IUD worked in that way as well – I wonder if that’s why periods can be so painful and cramping is often prevalent. It’s essentially a constant irritant.

    Anyway, I really am optimistic about Centchroman and everyone seems to be very happy about it but I would like to be fully informed. I suppose the fact that it comes from India and not approved by the FDA makes me a little wary as well.

    Thank you for your response.
    Last edited by a moderator: Sep 8, 2013

     
  15. gds

    gds New Member

    Creads,

    not a problem, we are all here to support and help each other. I just get a little riled with sensationalism! I realise that wasn't what you meant to do, but it is a very touchy subject with some people.

    Yes, IUD's basically work by constantly irritating the uterus, and preventing implantation (to the best of my knowledge). I have never known anyone with one personally, although I have heard some nasty stories. There is an x-ray in one of my textbooks where an IUD broke through the uterine lining and was lodged up underneath the diaphragm. Ugh.

    There is a _lot_ of threads to get through, and lots of the early information and discussions are buried within the original two threads that are both around 40 pages long (they are in an archive area on the site somewhere). It takes a fair bit of time to wade through them all!

    G

     
  16. boycottthepill

    boycottthepill New Member

    Can someone help me understand the clinical trials featured on the john hopkins website. Now it says the druation of use wa 13,483 months? Is this correct? that's a lot of months. =)

     
  17. RaeS

    RaeS New Member

    lol btp~

    That's the total number of months of use by the women in the study, added up. Most of those months were experienced simultaneously by many women.

    i.e.: Say there were 6,000 women in the study. Each of these women were studied for 2 1/2 months. 6,000 x 2.5 = 15,000 total months studied.

    Very rough example, but I hope it illustrates what I'm getting at...

     
  18. boycottthepill

    boycottthepill New Member

    oh ok, that makes more sense. Thanks!

     
  19. boycottthepill

    boycottthepill New Member

    so according to the john hopkins websites the women were only on centchroman for not even a year?

     
  20. MyrtleWarbler

    MyrtleWarbler Super Moderator Staff Member

    Looks like the first trial was about 15 months and nearly 900 women, but the second trial (different dosage regime) was shorter and fewer women. Research conducted much earlier to establish basic safety was done over a couple years. No one should rely solely on the JH website for any info, because it's a "static" informational page summarizing only some of the published science at that time. It's not like those clinical trials are the only time women have been monitored while taking centchroman. There has been other research. More importantly, there has been extensive post-marketing surveillance of women taking Centchroman, but those results haven't been so neatly published for public review. It would be nice to see more of that data - a good question for Dr. NV, or Dr. Singh himself. When I get a chance... In the meantime, if you PM me your email address, I can send you a much longer document (peer-reviewed article) that reviews all the work involving development of Centchroman as a contraceptive. FroggieBet has collected some other articles, from her university library. We have talked about finding a free site where we could post them for access as a "library." We'll revisit this idea. Gotta be careful, with copyright laws... but PM her and she'll send you everything you want. I only have some of them.

     

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