Clinical trial NCT00160199: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Amenorrhea
Keywords: To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Secretory Conversion of the Endometrium
timeFrame: End of the study (Days 85)
measure: Number of Subjects With Withdrawal Bleeding
timeFrame: After first and second cycle (cycle=28 days)
Secondary outcomes:
measure: Maximum Intensity of Withdrawal Bleeding After Any Cycle
timeFrame: Duration of withdrawal bleed
measure: The Duration of Withdrawal Bleeding After the First Treatment Cycle
timeFrame: End of the first cycle of treatment (cycle=28 days)
measure: The Duration of Withdrawal Bleeding After Second Treatment Cycle
timeFrame: End of the second cycle of treatment (cycle=28 days)
measure: Time to Withdrawal Bleeding After First Treatment Cycle
timeFrame: End of the first cycle of treatment (cycle=28 days)
measure: Time to Withdrawal Bleeding After Second Treatment Cycle
timeFrame: End of the second cycle of treatment (cycle=28 days)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Site 29
state: Alabama
city: Montgomery
country: United States
facility: Site 41
state: Alabama
city: Tucson
country: United States
facility: Site 26
state: Arizona
city: Jonesboro
country: United States
facility: Site 5
state: Arkansas
city: Carmichael
country: United States
facility: Site 39
state: California
city: Encinitas
country: United States
facility: Site 17
state: California
city: San Diego
country: United States
facility: Site 10
state: California
city: Avon
country: United States
facility: Site 42
state: Connecticut
city: Groton
country: United States
facility: Site 3
state: Connecticut
city: New Britian
country: United States
facility: Site 22
state: Connecticut
city: Waterbury
country: United States
facility: Site 9
state: Connecticut
city: West Hartford
country: United States
facility: Site 37
state: Connecticut
city: Aventura
country: United States
facility: Site 14
state: Florida
city: Clearwater
country: United States
facility: Site 40
state: Florida
city: West Palm Beach
country: United States
facility: Site 1
state: Florida
city: West Palm Beach
country: United States
facility: Site 30
state: Florida
city: Atlanta
country: United States
facility: Site 46
state: Georgia
city: Powder Springs
country: United States
facility: Site 43
state: Georgia
city: Champaign
country: United States
facility: Site 36
state: Illinois
city: Chicago
country: United States
facility: Site 12
state: Illinois
city: Baton Rouge
country: United States
facility: Site 6
state: Louisiana
city: Baltimore
country: United States
facility: Site 7
state: Maryland
city: St. Louis
country: United States
facility: Site 2
state: Missouri
city: Reno
country: United States
facility: Site 16
state: Nevada
city: New York
country: United States
facility: Site 45
state: New York
city: New Bern
country: United States
facility: Site 23
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 15
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 28
state: North Carolina
city: Cincinnati
country: United States
facility: Site 33
state: Ohio
city: Erie
country: United States
facility: Site 32
state: Pennsylvania
city: Hershey
country: United States
facility: Site 47
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 44
state: Pennsylvania
city: Pottstown
country: United States
facility: Site 38
state: Pennsylvania
city: Greenville
country: United States
facility: Site 13
state: South Carolina
city: Conroe
country: United States
facility: Site 8
state: Texas
city: Corpus Christi
country: United States
facility: Site 11
state: Texas
city: Houston
country: United States
facility: Site 27
state: Texas
city: Houston
country: United States
facility: Site 34
state: Texas
city: San Antonio
country: United States
facility: Site 24
state: Texas
city: Salt Lake City
country: United States
facility: Site 35
state: Utah
city: Norfolk
country: United States
facility: Site 19
state: Virginia
city: Seattle
country: United States
facility: Site 4
state: Washington
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: