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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160199
First received: September 8, 2005
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Secondary Amenorrhea
Drug: PROMETRIUM® 300 mg
Drug: PROMETRIUM® 400 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Secretory Conversion of the Endometrium [ Time Frame: End of the study (Days 85) ] [ Designated as safety issue: No ]
    Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.

  • Number of Subjects With Withdrawal Bleeding [ Time Frame: After first and second cycle (cycle=28 days) ] [ Designated as safety issue: No ]
    This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.


Secondary Outcome Measures:
  • Maximum Intensity of Withdrawal Bleeding After Any Cycle [ Time Frame: Duration of withdrawal bleed ] [ Designated as safety issue: No ]
    The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy

  • The Duration of Withdrawal Bleeding After the First Treatment Cycle [ Time Frame: End of the first cycle of treatment (cycle=28 days) ] [ Designated as safety issue: No ]
    The numbers of days the subjects actually bled after the end of the first treatment cycle.

  • The Duration of Withdrawal Bleeding After Second Treatment Cycle [ Time Frame: End of the second cycle of treatment (cycle=28 days) ] [ Designated as safety issue: No ]
    The numbers of days the subjects actually bled after the end of the second treatment cycle

  • Time to Withdrawal Bleeding After First Treatment Cycle [ Time Frame: End of the first cycle of treatment (cycle=28 days) ] [ Designated as safety issue: No ]
    The number of days between the first cycle of treatment and the withdrawal bleeding.

  • Time to Withdrawal Bleeding After Second Treatment Cycle [ Time Frame: End of the second cycle of treatment (cycle=28 days) ] [ Designated as safety issue: No ]
    The number of days between the second cycle of treatment and the withdrawal bleeding


Enrollment: 240
Study Start Date: November 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160199

  Show 42 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cindy Lane, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160199     History of Changes
Other Study ID Numbers: S168.4.002
Study First Received: September 8, 2005
Results First Received: February 11, 2010
Last Updated: June 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea

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 July 09, 2014