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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196391
First Posted: September 20, 2005
Last Update Posted: July 30, 2014
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.
Information provided by:
Teva Pharmaceutical Industries
September 13, 2005
September 20, 2005
July 30, 2014
September 2005
April 2007   (Final data collection date for primary outcome measure)
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. [ Time Frame: Throughout study period ]
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Complete list of historical versions of study NCT00196391 on ClinicalTrials.gov Archive Site
Time to onset, duration, and severity of withdrawal bleeding. [ Time Frame: Throughout study ]
Time to onset, duration, and severity of withdrawal bleeding.
Not Provided
Not Provided
 
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Amenorrhea
  • Drug: DR-2021a
    1 capsule daily for 10 days
    Other Name: Micronized progesterone
  • Drug: DR-2021b
    1 capsule daily for 10 days
    Other Name: Micronized Progesterone
  • Drug: DR-2021c
    1 capsule daily for 10 days
    Other Name: Micronized Progesterone
  • Drug: DR-2021d
    1 capsule daily for 10 days
    Other Name: Micronized Progesterone
  • Drug: DR-2021e
    1 capsule daily for 10 days
  • Other: Placebo
    1 matching placebo capsule for 10 days
  • Experimental: 1
    Intervention: Drug: DR-2021a
  • Experimental: 2
    Intervention: Drug: DR-2021b
  • Experimental: 3
    Intervention: Drug: DR-2021c
  • Experimental: 4
    Intervention: Drug: DR-2021d
  • Experimental: 5
    Intervention: Drug: DR-2021e
  • Placebo Comparator: 6
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 2007
April 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00196391
DR-MPG-201
No
Not Provided
Not Provided
Duramed Protocol Chair, Duramed Research, Inc.
Duramed Research
Not Provided
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
Teva Pharmaceutical Industries
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP