search
Back to results

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

Primary Purpose

Secondary Amenorrhea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PROMETRIUM® 300 mg
PROMETRIUM® 400 mg
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Amenorrhea focused on measuring To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site 29
  • Site 41
  • Site 26
  • Site 5
  • Site 39
  • Site 17
  • Site 10
  • Site 42
  • Site 3
  • Site 22
  • Site 9
  • Site 37
  • Site 14
  • Site 40
  • Site 1
  • Site 30
  • Site 46
  • Site 43
  • Site 36
  • Site 12
  • Site 6
  • Site 7
  • Site 2
  • Site 16
  • Site 45
  • Site 23
  • Site 15
  • Site 28
  • Site 33
  • Site 32
  • Site 47
  • Site 44
  • Site 38
  • Site 13
  • Site 8
  • Site 11
  • Site 27
  • Site 34
  • Site 24
  • Site 35
  • Site 19
  • Site 4

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Secretory Conversion of the Endometrium
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
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
The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
The Duration of Withdrawal Bleeding After the First Treatment Cycle
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
The numbers of days the subjects actually bled after the end of the second treatment cycle
Time to Withdrawal Bleeding After First Treatment Cycle
The number of days between the first cycle of treatment and the withdrawal bleeding.
Time to Withdrawal Bleeding After Second Treatment Cycle
The number of days between the second cycle of treatment and the withdrawal bleeding

Full Information

First Posted
September 8, 2005
Last Updated
June 30, 2010
Sponsor
Solvay Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00160199
Brief Title
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Amenorrhea
Keywords
To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PROMETRIUM® 300 mg
Intervention Description
300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
Intervention Type
Drug
Intervention Name(s)
PROMETRIUM® 400 mg
Intervention Description
400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
Primary Outcome Measure Information:
Title
Secretory Conversion of the Endometrium
Description
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Time Frame
End of the study (Days 85)
Title
Number of Subjects With Withdrawal Bleeding
Description
This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
Time Frame
After first and second cycle (cycle=28 days)
Secondary Outcome Measure Information:
Title
Maximum Intensity of Withdrawal Bleeding After Any Cycle
Description
The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
Time Frame
Duration of withdrawal bleed
Title
The Duration of Withdrawal Bleeding After the First Treatment Cycle
Description
The numbers of days the subjects actually bled after the end of the first treatment cycle.
Time Frame
End of the first cycle of treatment (cycle=28 days)
Title
The Duration of Withdrawal Bleeding After Second Treatment Cycle
Description
The numbers of days the subjects actually bled after the end of the second treatment cycle
Time Frame
End of the second cycle of treatment (cycle=28 days)
Title
Time to Withdrawal Bleeding After First Treatment Cycle
Description
The number of days between the first cycle of treatment and the withdrawal bleeding.
Time Frame
End of the first cycle of treatment (cycle=28 days)
Title
Time to Withdrawal Bleeding After Second Treatment Cycle
Description
The number of days between the second cycle of treatment and the withdrawal bleeding
Time Frame
End of the second cycle of treatment (cycle=28 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 29
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Site 41
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Site 26
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Site 5
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
Site 39
City
Carmichael
State/Province
California
Country
United States
Facility Name
Site 17
City
Encinitas
State/Province
California
Country
United States
Facility Name
Site 10
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 42
City
Avon
State/Province
Connecticut
Country
United States
Facility Name
Site 3
City
Groton
State/Province
Connecticut
Country
United States
Facility Name
Site 22
City
New Britian
State/Province
Connecticut
Country
United States
Facility Name
Site 9
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Site 37
City
West Hartford
State/Province
Connecticut
Country
United States
Facility Name
Site 14
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Site 40
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Site 1
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Site 30
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Site 46
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 43
City
Powder Springs
State/Province
Georgia
Country
United States
Facility Name
Site 36
City
Champaign
State/Province
Illinois
Country
United States
Facility Name
Site 12
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 6
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Site 7
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Site 2
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 16
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Site 45
City
New York
State/Province
New York
Country
United States
Facility Name
Site 23
City
New Bern
State/Province
North Carolina
Country
United States
Facility Name
Site 15
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Site 28
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Site 33
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 32
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
Site 47
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Site 44
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 38
City
Pottstown
State/Province
Pennsylvania
Country
United States
Facility Name
Site 13
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Site 8
City
Conroe
State/Province
Texas
Country
United States
Facility Name
Site 11
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
Site 27
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 34
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 24
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 35
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Site 19
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Site 4
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs