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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 27 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

Additional Information:
Mayo Clinic - Amenorrhea  This link exits the ClinicalTrials.gov site

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 October 16, 2012