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

Phase 2

Completed

• Conditions: Amenorrhea
• Interventions: Drug: DR-2021b; Drug: DR-2021c; Drug: DR-2021d; Drug: DR-2021e; Other: Placebo; Drug: DR-2021a

• Registration Number: NCT00196391
• Lead Sponsor: Duramed Research

Brief 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.

Detailed Description

In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	DR-2021b	-
3	DR-2021c	-
4	DR-2021d	-
5	DR-2021e	-
6	Placebo	-
1	DR-2021a	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.	Throughout study period

Secondary Outcome Measures

Name	Time	Method
Time to onset, duration, and severity of withdrawal bleeding.	Throughout study

Trial Locations

Locations (2)

Duramed Investigational Ste; 🇺🇸 Dawsonville, Georgia, United States

Duramed Investigational Site; 🇺🇸 Newport News, Virginia, United States