Clinical trial NCT01178125: A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-102) for the Prevention of Pregnancy in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Female Contraception
Keywords: Pregnancy Prevention
Oral Contraceptives
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 2858
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.


Eligibility criteria: Inclusion Criteria:

* Sexually active at risk for pregnancy
* Agreement to use study oral contraceptive therapy as their only method of birth control during the study
* History of regular spontaneous menstrual cycles or withdrawal bleeding episodes
* Others as dictated by protocol

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy or plans to become pregnant in the next 14 months
* Smoker and age greater than or equal to 35 years
* Others as dictated by protocol

Primary outcomes:
measure: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
measure: Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
measure: Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
Secondary outcomes:
measure: All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: thirteen 28-day cycles
measure: Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: thirteen 28-day cycles
measure: Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
measure: Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
measure: Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
measure: Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
measure: Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
measure: Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
timeFrame: thirteen 28-day cycles
Other outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
timeFrame: Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
measure: Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
timeFrame: Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)
Locations:
city: Montgomery
country: United States
facility: Teva Investigational Site 10007
state: Alabama
city: Phoenix
country: United States
facility: Teva Investigational Site 10013
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 10017
state: Arizona
city: Little Rock
country: United States
facility: Teva Investigational Site 10032
state: Arkansas
city: San Diego
country: United States
facility: Teva Investigational Site 10026
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10056
state: California
city: Colorado Springs
country: United States
facility: Teva Investigational Site 10002
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 10033
state: Colorado
city: Washington
country: United States
facility: Teva Investigational Site 10057
state: District of Columbia
city: Clearwater
country: United States
facility: Teva Investigational Site 10052
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 10021
state: Florida
city: Leesburg
country: United States
facility: Teva Investigational Site 10036
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10012
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10015
state: Florida
city: Palm Beach Gardens
country: United States
facility: Teva Investigational Site 10055
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 10001
state: Florida
city: Decatur
country: United States
facility: Teva Investigational Site 10031
state: Georgia
city: Roswell
country: United States
facility: Teva Investigational Site 10041
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 10050
state: Georgia
city: Louisville
country: United States
facility: Teva Investigational Site 10008
state: Kentucky
city: Mount Sterling
country: United States
facility: Teva Investigational Site 10023
state: Kentucky
city: Lawrenceville
country: United States
facility: Teva Investigational Site 10048
state: New Jersey
city: Moorestown
country: United States
facility: Teva Investigational Site 10030
state: New Jersey
city: Albuquerque
country: United States
facility: Teva Investigational Site 10014
state: New Mexico
city: Rochester
country: United States
facility: Teva Investigational Site 10006
state: New York
city: Cary
country: United States
facility: Teva Investigational Site 10044
state: North Carolina
city: Charlotte
country: United States
facility: Teva Investigational Site 10040
state: North Carolina
city: New Bern
country: United States
facility: Teva Investigational Site 10034
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 10018
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 10046
state: North Carolina
city: Columbus
country: United States
facility: Teva Investigational Site 10022
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 10039
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10028
state: Oklahoma
city: Philadelphia
country: United States
facility: Teva Investigational Site 10043
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 10003
state: Pennsylvania
city: Bluffton
country: United States
facility: Teva Investigational Site 10049
state: South Carolina
city: Columbia
country: United States
facility: Teva Investigational Site 10037
state: South Carolina
city: Greenville
country: United States
facility: Teva Investigational Site 10035
state: South Carolina
city: Mount Pleasant
country: United States
facility: Teva Investigational Site 10047
state: South Carolina
city: Jackson
country: United States
facility: Teva Investigational Site 10016
state: Tennessee
city: Knoxville
country: United States
facility: Teva Investigational Site 10045
state: Tennessee
city: Memphis
country: United States
facility: Teva Investigational Site 10005
state: Tennessee
city: Nashville
country: United States
facility: Teva Investigational Site 10042
state: Tennessee
city: Dallas
country: United States
facility: Teva Investigational Site 10054
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 10019
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10020
state: Texas
city: Arlington
country: United States
facility: Teva Investigational Site 10038
state: Virginia
city: Norfolk
country: United States
facility: Teva Investigational Site 10024
state: Virginia
city: Norfolk
country: United States
facility: Teva Investigational Site 10051
state: Virginia
city: Richmond
country: United States
facility: Teva Investigational Site 10053
state: Virginia
city: Seattle
country: United States
facility: Teva Investigational Site 10027
state: Washington
city: Tacoma
country: United States
facility: Teva Investigational Site 10029
state: Washington
city: Beer Sheva
country: Israel
facility: Teva Investigational Site 80108
city: Givataim
country: Israel
facility: Teva Investigational Site 80109
city: Haifa
country: Israel
facility: Teva Investigational Site 80104
city: Haifa
country: Israel
facility: Teva Investigational Site 80107
city: Modi'in
country: Israel
facility: Teva Investigational Site 80101
city: Or-Yehuda
country: Israel
facility: Teva Investigational Site 80103
city: Petach-Tikva
country: Israel
facility: Teva Investigational Site 80100
city: RishonLe'zio
country: Israel
facility: Teva Investigational Site 80105
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 80102
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 80106
Study officials:
affiliation: Teva Women's Health
name: Teva Women's Health Research Protocol Chair
role: STUDY_CHAIR
References: