Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

June 30, 2010 updated by: Solvay Pharmaceuticals

Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea

To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
        • Site 29
      • Montgomery, Alabama, United States
        • Site 41
    • Arizona
      • Tucson, Arizona, United States
        • Site 26
    • Arkansas
      • Jonesboro, Arkansas, United States
        • Site 5
    • California
      • Carmichael, California, United States
        • Site 39
      • Encinitas, California, United States
        • Site 17
      • San Diego, California, United States
        • Site 10
    • Connecticut
      • Avon, Connecticut, United States
        • Site 42
      • Groton, Connecticut, United States
        • Site 3
      • New Britian, Connecticut, United States
        • Site 22
      • Waterbury, Connecticut, United States
        • Site 9
      • West Hartford, Connecticut, United States
        • Site 37
    • Florida
      • Aventura, Florida, United States
        • Site 14
      • Clearwater, Florida, United States
        • Site 40
      • West Palm Beach, Florida, United States
        • Site 1
      • West Palm Beach, Florida, United States
        • Site 30
    • Georgia
      • Atlanta, Georgia, United States
        • Site 46
      • Powder Springs, Georgia, United States
        • Site 43
    • Illinois
      • Champaign, Illinois, United States
        • Site 36
      • Chicago, Illinois, United States
        • Site 12
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Site 6
    • Maryland
      • Baltimore, Maryland, United States
        • Site 7
    • Missouri
      • St. Louis, Missouri, United States
        • Site 2
    • Nevada
      • Reno, Nevada, United States
        • Site 16
    • New York
      • New York, New York, United States
        • Site 45
    • North Carolina
      • New Bern, North Carolina, United States
        • Site 23
      • Winston-Salem, North Carolina, United States
        • Site 15
      • Winston-Salem, North Carolina, United States
        • Site 28
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 33
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • Site 32
      • Hershey, Pennsylvania, United States
        • Site 47
      • Philadelphia, Pennsylvania, United States
        • Site 44
      • Pottstown, Pennsylvania, United States
        • Site 38
    • South Carolina
      • Greenville, South Carolina, United States
        • Site 13
    • Texas
      • Conroe, Texas, United States
        • Site 8
      • Corpus Christi, Texas, United States
        • Site 11
      • Houston, Texas, United States
        • Site 27
      • Houston, Texas, United States
        • Site 34
      • San Antonio, Texas, United States
        • Site 24
    • Utah
      • Salt Lake City, Utah, United States
        • Site 35
    • Virginia
      • Norfolk, Virginia, United States
        • Site 19
    • Washington
      • Seattle, Washington, United States
        • Site 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with secondary amenorrhea
  • Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine

Exclusion Criteria:

  • Primary amenorrhea
  • Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
  • Peanut allergy
  • Allergy to progestational steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: PROMETRIUM® 300 mg
300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
Active Comparator: 2
Drug: PROMETRIUM® 400 mg
400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secretory Conversion of the Endometrium
Time Frame: End of the study (Days 85)
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
End of the study (Days 85)
Number of Subjects With Withdrawal Bleeding
Time Frame: After first and second cycle (cycle=28 days)
This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
After first and second cycle (cycle=28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Intensity of Withdrawal Bleeding After Any Cycle
Time Frame: Duration of withdrawal bleed
The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
Duration of withdrawal bleed
The Duration of Withdrawal Bleeding After the First Treatment Cycle
Time Frame: End of the first cycle of treatment (cycle=28 days)
The numbers of days the subjects actually bled after the end of the first treatment cycle.
End of the first cycle of treatment (cycle=28 days)
The Duration of Withdrawal Bleeding After Second Treatment Cycle
Time Frame: End of the second cycle of treatment (cycle=28 days)
The numbers of days the subjects actually bled after the end of the second treatment cycle
End of the second cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After First Treatment Cycle
Time Frame: End of the first cycle of treatment (cycle=28 days)
The number of days between the first cycle of treatment and the withdrawal bleeding.
End of the first cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After Second Treatment Cycle
Time Frame: End of the second cycle of treatment (cycle=28 days)
The number of days between the second cycle of treatment and the withdrawal bleeding
End of the second cycle of treatment (cycle=28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

June 30, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S168.4.002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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