NORETHINDRONE ACETATE
NORETHINDRONE ACETATE is indicated for the treatment of Secondary Amenorrhea; Endometriosis; Abnormal Uterine Bleeding.
Details
- Status
- Prescription
- First Approved
- 2001-05-25
- Routes
- ORAL
- Dosage Forms
- TABLET
NORETHINDRONE ACETATE Approval History
What NORETHINDRONE ACETATE Treats
3 indicationsNORETHINDRONE ACETATE is approved for 3 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Amenorrhea
- Endometriosis
- Abnormal Uterine Bleeding
NORETHINDRONE ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NORETHINDRONE ACETATE
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04527003 results posted | STUDY00013752 | Ph 3 | terminated | Cannabidiol and Management of Endometriosis Pain |
| NCT03970330 results posted | Study00011187 | Ph 3 | terminated | Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis |
| NCT02542410 results posted | P00018628 | Ph 2 | completed | Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study |
| NCT01140217 Simplify | NE0906 | Ph 3 | completed | Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NORETHINDRONE ACETATE FDA Label Details
Indications & Usage
FDA Label (PDF)NORETHINDRONE ACETATE is indicated for the treatment of Secondary Amenorrhea; Endometriosis; Abnormal Uterine Bleeding.
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AYGESTIN
Full clinical data, patents, trials, and competitive landscape for norethindrone acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.