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NCT00196391 Clinical Trial

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

Amenorrhea Clinical Trial

Official title:
A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00196391
Other study ID # DR-MPG-201
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated July 29, 2014
Start date September 2005
Est. completion date April 2007

Study information
Verified date May 2014
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DR-2021a
1 capsule daily for 10 days
• DR-2021b
1 capsule daily for 10 days
• DR-2021c
1 capsule daily for 10 days
• DR-2021d
1 capsule daily for 10 days
• DR-2021e
1 capsule daily for 10 days
Other:
• Placebo
1 matching placebo capsule for 10 days

Locations
Country Name City State
United States Duramed Investigational Site Alliance Nebraska
United States Duramed Investigational Site Atlanta Georgia
United States Duramed Investigational Site Carmichael California
United States Duramed Investigational Site Colorado Springs Colorado
United States Duramed Investigational Site Columbia South Carolina
United States Duramed Investigational Site Dallas Texas
United States Duramed Investigational Ste Dawsonville Georgia
United States Duramed Investigational Site Douglasville Georgia
United States Duramed Investigational Site Gainesville Florida
United States Duramed Investigational Site Houston Texas
United States Duramed Investigational Site Houston Texas
United States Duramed Investigational Site Laurel Maryland
United States Duramed Investigational Site Lawrenceville New Jersey
United States Duramed Investigational Site Leesburg Florida
United States Duramed Investigational Site Medford Oregon
United States Duramed Investigational Site Memphis Tennessee
United States Duramed Investigational Site Miami Florida
United States Duramed Investigational Site Mobile Alabama
United States Duramed Investigational Site Newport News Virginia
United States Duramed Investigational Site Phoenix Arizona
United States Duramed Investigational Site Pittsburgh Pennsylvania
United States Duramed Investigational Site Pueblo Colorado
United States Duramed Investigational Site San Diego California
United States Duramed Investigational Site San Diego California
United States Duramed Investigational Site St. Louis Missouri
United States Duramed Investigational Site Tucson Arizona
United States Duramed Investigational Site Willow Grove Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. Throughout study period No
Secondary Time to onset, duration, and severity of withdrawal bleeding. Throughout study No
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