Saheli FAQ

Saheli (aka Centchroman) is the world’s first non-hormonal oral contraceptive pill. Launched in 1991, this pill has provided contraception to over 10,000,000 women in India and throughout the world.
Saheli’s contraceptive action happens by preventing egg implantation in the uterus.
Saheli is a Selective Estrogen Receptor Modulator (SERM) which acts in a unique way to prevent pregnancy. It does not affect the estrogen levels like other birth control pills. Instead, it suppresses estrogen receptors in the uterus preventing development of the uterine lining.
The contraceptive action of Saheli is caused by asynchrony created in preparing the uterus for implantation. Since there is no disturbance of the endocrine system, normal ovulatory cycle is maintained. Side effects commonly associated with hormonal pills are absent with Saheli. The contraceptive effect is completely reversible and future pregnancy is normal. The safety and dosage simplicity makes Saheli a great birth control option.
Follow these instructions carefully.

It is important to use backup protection such a condom, diaphragm, or IUD for the first 3 months of usage while your body adjusts to Saheli's contraceptive effect.

Start taking Saheli, 1 tablet twice a week for 3 months. For instance, if you take the first pill on a Sunday take the second one on Wednesday. From the fourth month onwards, take only one tablet once a week for as long as you want to prevent pregnancy.

The first pill should be taken on the first day of the menstrual cycle, (as indicated by the first day of bleeding).

Continue taking Saheli on all the Saheli days irrespective of the onset of the subsequent menstrual cycles. This is important because in clinical trials it has been reported that 8% of cycles are delayed. In the event the subsequent periods are delayed, the tablets should be taken as per the days fixed when the first pill was taken. However, if the delay is more than 15 days, you should consult your doctor.
A simplified dosage schedule chart given below will help in identifying days on which you need to take Saheli tablets. As an extra precaution, some women choose to take Saheli every 5 days after 3 months, but this is not normally necessary.

To know and remember your Saheli days, refer to the following table.
Saheli offers 95-99% pregnancy protection as documented during the clinical trials and post marketing surveillance. The Pearl Index (Contraceptive failure rate in 100 woman years of use) of Saheli as documented in trials of CDRI is 1.63 and during the post marketing surveillance the Pearl Index reported is 1.13. A 2016 medical study on Centchroman published in the Journal of Evidence Based Medicine and Healthcare found the Pearl Index to be 2. Other studies found below, have shown a failure rate of up to 5%.
If you have missed taking a Saheli pill on the designated Saheli day, take it as soon as possible. If you have missed your pill dosage by one or two days but lesser than seven days, continue the normal schedule and also consider using backup protection as additional precaution till you get your next period. If you forgot Saheli by more than seven days, you need to start taking it all over again, like a new user that is twice a week for three months then once a week.
With Saheli, occasionally the menstrual cycle may get prolonged in some users. As Saheli acts as a contraceptive, it makes the periods lighter and the interval longer. This is not harmful for the body and can actually help increase your body’s supply of iron as you lose less amount of blood. If your period is delayed, you can choose to take a pregnancy test and consult a doctor. If your periods are delayed by more than 15 days consult a doctor. If you think you are pregnant, it is not recommended to continue Saheli usage, please consult a doctor, and strongly consider an early ultrasound to assure health and safety.
Saheli is free from side effects commonly associated with steroidal oral contraceptives like weight gain, nausea, vomiting, dizziness and breakthrough bleeding, breast tenderness, acne, hirsuitism. Saheli maintains normal ovulatory cycle as it has no effect on the Hypothalamo-Pituitary-Ovarian axis.

-Saheli possesses no effect on platelet aggregation, lipid profile and HDL cholesterol.

-Saheli ensures excellent user compliance because of its safety and dosage simplicity.

-Saheli exhibits contraceptive activity which is readily reversible within 6 months and subsequent pregnancy is normal.

-Saheli has been found to be effective in managing Dysfunctional Uterine Bleeding.
Saheli has few known side effects. Some women experience prolonged menstrual cycles, some have lighter cycles. In the first three months of use, as the body adjusts, and a double dose is taken, few women experience heavier periods and/or occasional hot flashes, which normally pass after a few months usage.
Clinical studies have confirmed Saheli is safe and free from typical hormonal side effects such as nausea, weight gain, fluid retention, hypertension, etc. No cases of vaginal discharge, spotting, breakthrough bleeding or menorrhagia have been reported.
The post marketing surveillance indicate no abnormality of female genital tract (vagina, cervix, uterus and ovaries). Ultrasonography monitoring indicate little to no abnormal change in the size and volume of ovaries. If you are concerned about adverse effects, please thoroughly read studies referenced below for full details and to ensure that you are fully informed before use.
Women with the following conditions should not use Saheli:

-Polycystic ovarian disease

-Cervical hyperplasia

-Recent history of clinical evidence of jaundice or liver disease

-Severe allergic states, chronic illnesses such as tuberculosis, renal diseases, etc.
Studies conducted by CDRI indicate that Saheli could safely be used by lactating mothers.
No. You must stop using hormonal birth control before starting to use Saheli.
Saheli has a low effect for harmful interactions with other medicines. The co-administration of Ibuprofen, Rifampicin, Salbutamol, Diazepam, Paracetamol and Haloperidol do not affect the pharmacokinetics or efficacy of Saheli. Tetracycline and Amoxycilin may lower the bio-availability of Saheli. During treatment with these antibiotics, it is advisable to use backup protection until your next period.
No. Saheli has been safety tested and approved for use in India my the Indian Health Ministry since 1991. Over 10 million women have used it. Medical studies (found in the links in FAQs below) have proven its relative safety and effectiveness. However, Saheli has never gone through the process of seeking FDA or EU Pharma approval. The Indian government produces Saheli for its own people, and has no interest in marketing it internationally. We may assume that Big Pharma in the West has its own agenda in preventing Centchroman from international distribution as well.
Saheli is manufactured in India by HLL Lifecare. MyBody1 does not produce Saheli.
Saheli is packaged in a strip of eight tablets, which is 2 months supply for regular users, and 1 month supply for new users (for your first 3 months).
Please thoroughly read studies in the FAQ question below.

In the past, Johns Hopkins University study stated that all evidence indicates that Centchroman:


– is highly effective (only 1.63 pregnancies per 100 women during the first year), safe and easy to use (requires no pelvic examination prior to starting the drug); .

– is free from side effects commonly associated with steroidal oral contraceptives like nausea, vomiting, weight gain and dizziness;

– does not delay return of fertility;

– has only one adverse effect, delayed rfienses, but this occurs in less than 10 percent of cycles and with good counseling should not decrease compliance and continuation rates;

– maintains normal ovulatory cycles because the low dose and weekly or biweekly administration schedule minimizes any effect on the hypothalamic-pituitary-ovarian axis;

– has no apparent adverse effects on endocrine, hematologic, liver and lipid function and, to date, has not been associated with any serious complications (heart attack, stroke or blood clots) that would limit its use by most women; and . does not appear to cause congenital anomalies in infants born because of user failure.

The CDRI (Central Drug Research Institute) adds that intensive monitoring by clinical examination, haematology and biochemical tests as well as laparascopy and ultrasonographic examinations of ovaries and uterus have shown the drug to be quite safe. Centchroman does not cause nausea, vomiting, dizziness and break through bleeding and has no adverse effect on lipid profile and platelet function as is seen with steroidal contraceptives. Babies born to use failure cases have shown normal milestones. The contraceptive effect is readily reversible and subsequent pregnancy and its outcome is normal. It scores over steroidal contraceptive pills because it does not disturb the endocrine system and the normal ovulatory cycle is maintained.

 

*Disclaimer: Statements regarding Saheli have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.