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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00196391
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 30, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Amenorrhea Drug: DR-2021a Drug: DR-2021b Drug: DR-2021c Drug: DR-2021d Drug: DR-2021e Other: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : September 2005
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196391


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

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196391     History of Changes
Other Study ID Numbers: DR-MPG-201
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: May 2014

Keywords provided by Teva Pharmaceutical Industries:
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