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

This study has been completed.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00196391
First received: September 13, 2005
Last updated: January 8, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Amenorrhea
Drug: DR-2021a
Drug: DR-2021b
Drug: DR-2021c
Drug: DR-2021d
Drug: DR-2021e
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea

Resource links provided by NLM:


Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset, duration, and severity of withdrawal bleeding. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-2021a
1 capsule daily for 10 days
Other Name: Micronized progesterone
Experimental: 2 Drug: DR-2021b
1 capsule daily for 10 days
Other Name: Micronized Progesterone
Experimental: 3 Drug: DR-2021c
1 capsule daily for 10 days
Other Name: Micronized Progesterone
Experimental: 4 Drug: DR-2021d
1 capsule daily for 10 days
Other Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196391

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

Additional Information:
No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196391     History of Changes
Other Study ID Numbers: DR-MPG-201
Study First Received: September 13, 2005
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
secondary amenorrhea
progesterone

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014