Danazol
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
- Danazol
- Pharmacist Assessment Report
- Danazol: Synthetic steroid with antigonadotropic activity → Amenorrhea (amenorrhea (disease))
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Danazol: Synthetic steroid with antigonadotropic activity → Amenorrhea (amenorrhea (disease))
One-Sentence Summary
Danazol is a synthetic steroid that suppresses the pituitary-ovarian axis and has androgenic effects. The TxGNN model predicts it may be useful for amenorrhea (disease), in the sense of therapeutic menstrual suppression. The data compiled for this report show no registered clinical trials and 20 publications, mostly older reviews and small clinical studies, with one recent cohort study of menstrual suppression.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Amenorrhea (amenorrhea (disease)) |
| TxGNN Prediction Score | 1.0000 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Published reviews describe danazol as a synthetic steroid that inhibits gonadotropin release (reducing the LH/FSH midcycle surge), suppresses ovarian and adrenal steroid production, and produces an anovulatory, low-estrogen, androgenic state with endometrial atrophy.
Amenorrhea is therefore an expected pharmacological effect of danazol, not a separate disease target. The prediction is mechanistically coherent, but the real use would be deliberate menstrual suppression rather than treatment of an underlying pathology. A 2024 multi-site retrospective cohort study evaluated danazol for menstrual suppression in transgender and nonbinary individuals, which is the closest direct evidence for this use.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39051650 | 2024 | Cohort | Women’s Health (London) | Retrospective multi-site study of danazol for menstrual suppression in transgender and nonbinary individuals; danazol can induce amenorrhea but causes androgenic effects such as voice change |
| 2523321 | 1989 | Clinical comparison | Fertility and Sterility | Randomized comparison of gestrinone vs danazol (600 mg/day) in 39 infertile women with endometriosis; amenorrhea was a treatment target |
| 2140996 | 1990 | Double-blind randomized study | Fertility and Sterility | Nafarelin vs danazol 600 mg/day in 82 women with endometriosis; both produced significant disease regression |
| 6210867 | 1982 | Double-blind dose study | Obstetrics and Gynecology | Danazol 100–600 mg/day for 6 months in 27 women with pelvic endometriosis; clinical improvement varied with dose |
| 2404115 | 1990 | Review | J Reprod Med | Danazol inhibits gonadotropins and suppresses gonadal and adrenal steroid production |
| 6819580 | 1982 | Review | Prog Clin Biol Res | Danazol suppresses ovarian function in endometriosis and infertility |
| 21701432 | 2011 | Review | Menopause | Evidence-based review of drug therapy for abnormal uterine bleeding |
| 16280355 | 2006 | Review | Hum Reprod Update | Endometriosis lesions regress during amenorrhea or menopause |
| 36434439 | 2023 | Systematic review (indirect) | Arch Gynecol Obstet | Gestrinone (not danazol) in endometriosis; induces endometrial atrophy and amenorrhea |
| 1533675 | 1992 | Review | J R Army Med Corps | Induction of amenorrhea in female military personnel; mainly discusses oral contraceptives and goserelin |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02018160 | CYCLOMEN | Not recorded | Not recorded |
| 02018152 | CYCLOMEN | Not recorded | Not recorded |
Safety Considerations
- Drug Interactions: 100 interactions were found in the interaction database. Examples include a major interaction with cisapride, and moderate interactions with several diabetes medicines (acarbose, glimepiride, glipizide, glyburide, insulin, and the gliflozins and GLP-1 agonists listed), as well as budesonide and eliglustat.
- Published case reports in the compiled literature describe raised carbamazepine levels with danazol and rhabdomyolysis with pancreatitis when danazol was combined with lovastatin.
- Androgenic adverse effects (such as voice change and hair pigmentation) are reported in the menstrual suppression cohort.
Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Amenorrhea is a well-understood pharmacological effect of danazol, and a recent cohort study directly examines menstrual suppression. However, no clinical trials are registered, the supporting literature is mostly old or indirect, and amenorrhea is an effect of treatment rather than a disease to be cured. Evidence level is L3.
To proceed, the following is needed:
- Health Canada package insert warnings and contraindications
- Mechanism of action data from a curated source
- Prospective or controlled data on menstrual suppression with danazol
- A monitoring plan for androgenic effects and drug interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.