Clinical trial NCT00196391: A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
Official title: A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amenorrhea
Keywords: secondary amenorrhea
progesterone
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.

Detailed description: In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.

Eligibility criteria: Inclusion Criteria:

* Not pregnant
* Secondary amenorrhea or oligomenorrhea of at least 50 days duration
* Not currently on any hormonal medication
* Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom)

Exclusion Criteria:

* Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months
* Use of any hormonal birth control within the last 3 months
* Any contraindication to the use of progestins

Primary outcomes:
measure: Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
timeFrame: Throughout study period
Secondary outcomes:
measure: Time to onset, duration, and severity of withdrawal bleeding.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Pueblo
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Dawsonville
country: United States
facility: Duramed Investigational Ste
state: Georgia
city: Douglasville
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Laurel
country: United States
facility: Duramed Investigational Site
state: Maryland
city: St. Louis
country: United States
facility: Duramed Investigational Site
state: Missouri
city: Alliance
country: United States
facility: Duramed Investigational Site
state: Nebraska
city: Lawrenceville
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: Newport News
country: United States
facility: Duramed Investigational Site
state: Virginia
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References: