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

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: September 13, 2005
Last updated: July 29, 2014
Last verified: May 2014
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
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. [ Time Frame: Throughout study period ]

Secondary Outcome Measures:
  • Time to onset, duration, and severity of withdrawal bleeding. [ Time Frame: Throughout study ]

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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00196391

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

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc. Identifier: NCT00196391     History of Changes
Other Study ID Numbers: DR-MPG-201
Study First Received: September 13, 2005
Last Updated: July 29, 2014

Keywords provided by Teva Pharmaceutical Industries:
secondary amenorrhea

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 22, 2017