Desogestrel
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Desogestrel: From Hormonal Contraception to Amenorrhea
One-Sentence Summary
Desogestrel is a progestin used in hormonal contraceptives, and it is marketed in India as a single-ingredient product. The TxGNN model predicts it may be useful for Amenorrhea, with 1 clinical trial and 11 publications currently linked to this direction. The evidence is indirect: most of it concerns combined oral contraceptives rather than desogestrel alone, so this should be treated as a research question rather than an established use.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration records (desogestrel is known as a contraceptive progestin) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 0.9996 |
| Evidence Level | L5 (weak; the only Phase 3 trial does not clearly study desogestrel) |
| India Market Status | Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data |
| Number of Listed Products | 3 (valid: 3) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, desogestrel is a progestin used in contraceptives. It suppresses the hypothalamic-pituitary-ovarian axis, and combined with ethinylestradiol it provides estrogen/progestin hormone support.
In young women with hypothalamic oligo/amenorrhea (for example, athletes), this kind of hormone support may help protect the endometrium and bone. One study (PMID 11725730) examined bone mineral density in young women with hypothalamic oligoamenorrhea treated with oral contraceptives.
There are important caveats. The supporting evidence is for combined oral contraceptives, not desogestrel alone. Amenorrhea is also a known effect of progestin-only pills, so desogestrel is not a cure for the condition. The mechanistic link is plausible but weak.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00946192 | Phase 3 | Completed | 121 | Young athletes with and without menstrual loss; tests whether transdermal or oral estrogen improves bone density in estrogen-deficient athletes. Desogestrel is not confirmed as the studied drug. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 11725730 | 2001 | Clinical study | J Reprod Med | Bone mineral density in young women with hypothalamic oligoamenorrhea treated with oral contraceptives of decreasing ethinylestradiol dose |
| 8447356 | 1993 | Tolerability study | Am J Obstet Gynecol | Desogestrel/ethinylestradiol tolerability and non-contraceptive benefits of oral contraceptives |
| 8218004 | 1993 | Comparative clinical study | Br J Obstet Gynaecol | Two desogestrel pills (20 vs 30 µg ethinylestradiol) compared for reliability, cycle control and side effects |
| 35261299 | 2022 | Clinical study | Gynecol Endocrinol | Bleeding profile of a drospirenone-only pill versus desogestrel 75 µg, noting amenorrhea as a progestin-only pill effect |
| 8324604 | 1993 | Review | Br Med Bull | Acceptability, safety and effective use of combined oral contraceptives |
| 1436906 | 1992 | Review | Obstet Gynecol Surv | Pills containing gestodene, norgestimate and desogestrel |
| 3161265 | 1985 | Pharmacodynamic study | Acta Obstet Gynecol Scand Suppl | Androgenicity of desogestrel alone and with ethinylestradiol |
| 8513962 | 1993 | Comparative study | Fertil Steril | GnRH agonist versus low-dose oral contraceptive for endometriosis pelvic pain |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 86437 | Femfolin 50mg Capsule (Lupin Ltd) | Strip of 10 capsules | Not stated |
| 34232 | Cerazette Tablet (Organon (India) Ltd) | Strip of 28 tablets | Not stated |
| 86642 | Famylette Tablet (Mylan Pharmaceuticals Pvt Ltd) | Packet of 28 tablets | Not stated |
Safety Considerations
- Disease-level cautions (from a knowledge graph, not label text): the drug is linked to contraindication or caution signals for hypertension, epilepsy, porphyria, liver disease, gallbladder disease, diabetes and hyperglycaemia, hypertriglyceridaemia, hypothyroidism, systemic lupus erythematosus, asthma, hypercalcaemia, female breast carcinoma, thrombophlebitis, uterine leiomyoma, and anxiety and mood disorders. These need confirmation against the package insert.
- Drug Interactions: 43 interactions were found, and all 20 listed are moderate. They are mainly with glucose-lowering drugs (insulins, metformin, GLP-1 agonists, DPP-4 inhibitors, SGLT2 inhibitors, nateglinide, rosiglitazone), plus metreleptin, aprepitant and glycerol phenylbutyrate.
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The only Phase 3 trial is on athletic amenorrhea and does not clearly study desogestrel. The literature is mostly about combined contraceptives. Progestin-only desogestrel is itself known to cause amenorrhea, which weakens the case for treating it. The prediction remains a research question.
To proceed, the following is needed:
- Confirm whether the Phase 3 trial (NCT00946192) actually included a desogestrel arm
- Desogestrel-specific clinical data in amenorrhea, separate from combined pills
- Mechanism of action data and package insert warnings and contraindications (India)
- A safety review, given the many disease-level cautions and the interactions with glucose-lowering drugs
Other predictions (lower priority): Acne has the second-strongest support (evidence level L3, with small studies of desogestrel-containing combined pills, e.g. PMIDs 8894800 and 8689881), but the effect comes from the estrogen/progestin combination. The remaining predictions (benign breast conditions, breast abscess, lactation disease, primary ovarian failure, fragile X carrier symptoms) rest on model prediction alone or on indirect evidence and are recommended as Hold.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.