A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duramed Research
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Not pregnant

• Secondary amenorrhea or oligomenorrhea of at least 50 days duration

• Not currently on any hormonal medication

• Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom)

Exclusion Criteria:

• Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months

• Use of any hormonal birth control within the last 3 months

• Any contraindication to the use of progestins