The first post in this thread is really a collaborative effort between GreenTea and SusanT. Although my name appears on it, most of the work in putting this Centchroman FAQ together is hers. Thank you, Susan! 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. 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, are nursing a baby under six months, 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 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 (listed below) and ask--it may or may not be. Edit on May 2, 2006: We have just learned that PCOS is not a real contraindication for Centchroman, and neither is ovarian cysts. The reason for it being listed as one on the insert is that women with PCOS were excluded from the clinical trials, on the grounds that it might be impossible to tell side effects of the drug from symptoms of their disease. There is no evidence that Centchroman would cause or exacerbate PCOS or ovarian cysts. See the post by greengrl on page 12 of this thread, fifth from the top. Edit on May 16, 2006: The package insert has been updated, and now it no longer lists nursing as a contraindication. Instead, it says Centchroman seems to be safe for lactating women. 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 discussion. 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. Backup protection is also advised (that is, barrier methods if you are sexually active), but the manufacturer does not give clear direction as to how long. Advice given in the internet discussion groups has been to use backup methods for the first two months, or even the first three months if you want to be super safe. From the thirteenth week on, it is taken once per week. 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. 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 . 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 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? Aphrodite Women’s Health first thread on Centchroman: http://www.aphroditewomenshealth.com/ubb/ultimatebb.php?/topic/4/4.html – The discussion that started it all. This topic is now closed, but users considering centchroman may wish to read the entire thread for additional information and experiences. MSN Group: http://groups.msn.com/Centchromanclub – Less discussion activity, but more users, many of whom are in India or are Indian expats, and several of whom are doctors or other medical professionals. Yahoo Group: http://health.groups.yahoo.com/group/centchroman/ – New discussion group, started by an Aphrodite member, populated mostly with users from outside of India. There is a section where you can access lengthy clinical documents published within recent years.