MENOPUR (menotropins (fsh)
MENOPUR is a gonadotropin indicated to assist in the development of multiple follicles and pregnancy in ovulatory women undergoing Assisted Reproductive Technology (ART). Before initiating treatment, patients must undergo comprehensive gynecologic and endocrinologic evaluations to identify the cause of infertility and rule out primary ovarian failure. The medication is used as part of a clinical protocol that includes assessing the male partner's fertility and confirming the patient is not pregnant.
How MENOPUR Works
MENOPUR is administered for a period of 7 to 20 days to stimulate ovarian follicular growth and maturation in women with functional ovaries. The medication acts as a gonadotropin to promote the development of follicles, though it generally does not trigger the release of the egg independently. Once sufficient follicular maturation is achieved, human chorionic gonadotropin (hCG) must be administered to induce ovulation.
Details
- Status
- Prescription
- First Approved
- 2004-10-29
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
MENOPUR Approval History
What MENOPUR Treats
1 indicationsMENOPUR is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Infertility
MENOPUR 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.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01417195 COMBINE results posted | FE999906 CS12 | Ph 4 | completed | Menopur Mixed Protocol |
| NCT01250821 | 2010-021459-16 | Ph 4 | completed | Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility |
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.
MENOPUR FDA Label Details
Indications & Usage
FDA Label (PDF)MENOPUR is indicated for the treatment of Infertility.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.