CompletedPhase 4

Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

United States240 participantsStarted 2004-11

Plain-language summary

To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with secondary amenorrhea * Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine Exclusion Criteria: * Primary amenorrhea * Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome) * Peanut allergy * Allergy to progestational steroids

What they're measuring

Secretory Conversion of the Endometrium

Timeframe: End of the study (Days 85)

Number of Subjects With Withdrawal Bleeding

Timeframe: After first and second cycle (cycle=28 days)

Trial details

NCT IDNCT00160199

SponsorSolvay Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-02

Results submitted2010-02-11

View on ClinicalTrials.gov More Secondary Amenorrhea trials