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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00160199
First Posted: September 12, 2005
Last Update Posted: July 7, 2010
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:
Solvay Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: None (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) ]
    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) ]
    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 ]
    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) ]
    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) ]
    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) ]
    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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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): NCT00160199


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

Responsible Party: Cindy Lane, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160199     History of Changes
Other Study ID Numbers: S168.4.002
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: February 11, 2010
Results First Posted: June 2, 2010
Last Update Posted: July 7, 2010
Last Verified: June 2010

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
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Menstruation Disturbances
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs