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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Progesterone

Criteria

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