TheraRadar
Data updated: May 26, 2026

AYGESTIN (norethindrone acetate)

Trial Activity: Declining
Women's Health Approved 1982-04-21
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Milton S. Hershey Medical Center conducting 2 trials (50%)
4 indications explored (Focused)
→ endometriosis (3 trials)
→ cbd (1 trials)
→ pelvic pain (1 trials)
1
Indication
--
Phase 3 Trials
44
Years on Market

Details

Status
Discontinued
First Approved
1982-04-21
Routes
ORAL
Dosage Forms
TABLET

Companies

DURAMED RES
Active Ingredient: NORETHINDRONE ACETATE

AYGESTIN Approval History

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Original
New Indication
New Form
Label Update
12 FDA actions from 1982 to 2007
Jul 2007 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Nov 2002 SUPPL
Mfg · Manufacturing (CMC)
Apr 2000 SUPPL
Label · Labeling

What AYGESTIN Treats

1 FDA approvals

Originally approved for its first indication in 1982 .

  • Other (1)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

AYGESTIN FDA Label Details

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Data Sources

FDA Approval: NDA018405 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment