CompletedPhase 2

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

United States180 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

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

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

What they're measuring

Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.

Timeframe: Throughout study period

Trial details

NCT IDNCT00196391

SponsorDuramed Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-04

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