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

July 29, 2014 updated by: Duramed Research

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Duramed Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Duramed Investigational Site
      • Tucson, Arizona, United States, 85712
        • Duramed Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Duramed Investigational Site
      • San Diego, California, United States, 92123
        • Duramed Investigational Site
      • San Diego, California, United States, 92130
        • Duramed Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Duramed Investigational Site
      • Pueblo, Colorado, United States, 81001
        • Duramed Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32605
        • Duramed Investigational Site
      • Leesburg, Florida, United States, 34748
        • Duramed Investigational Site
      • Miami, Florida, United States, 33143
        • Duramed Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Duramed Investigational Site
      • Dawsonville, Georgia, United States, 30534
        • Duramed Investigational Ste
      • Douglasville, Georgia, United States, 30134
        • Duramed Investigational Site
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Duramed Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Duramed Investigational Site
    • Nebraska
      • Alliance, Nebraska, United States, 69301
        • Duramed Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Duramed Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97505
        • Duramed Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Duramed Investigational Site
      • Willow Grove, Pennsylvania, United States, 19090
        • Duramed Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Duramed Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Duramed Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Duramed Investigational Site
      • Houston, Texas, United States, 77074
        • Duramed Investigational Site
      • Houston, Texas, United States, 77030
        • Duramed Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23602
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: DR-2021a
1 capsule daily for 10 days
Other Names:
  • Micronized progesterone
Experimental: 2
Drug: DR-2021b
1 capsule daily for 10 days
Other Names:
  • Micronized Progesterone
Experimental: 3
Drug: DR-2021c
1 capsule daily for 10 days
Other Names:
  • Micronized Progesterone
Experimental: 4
Drug: DR-2021d
1 capsule daily for 10 days
Other Names:
  • Micronized Progesterone
Experimental: 5
Drug: DR-2021e
1 capsule daily for 10 days
Placebo Comparator: 6
Other: Placebo
1 matching placebo capsule for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Time Frame: Throughout study period
Throughout study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to onset, duration, and severity of withdrawal bleeding.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-MPG-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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