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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2007

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Experimental: 4
• Experimental: 5
• Placebo Comparator: 6

Primary Measures

• Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
  • Time Frame: Throughout study period
    Safety Issue?: No

Secondary Measures

• Time to onset, duration, and severity of withdrawal bleeding.
  • Time Frame: Throughout study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Protocol Chair Study Chair Duramed Research, Inc.  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00196391

Study ID Number: DR-MPG-201

ClinicalTrials.gov Identifier: NCT00196391

Health Authority: United States: Food and Drug Administration

Mayo Clinic - Amenorrhea