A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy

November 8, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2858

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Teva Investigational Site 80108
      • Givataim, Israel
        • Teva Investigational Site 80109
      • Haifa, Israel
        • Teva Investigational Site 80104
      • Haifa, Israel
        • Teva Investigational Site 80107
      • Modi'in, Israel
        • Teva Investigational Site 80101
      • Or-Yehuda, Israel
        • Teva Investigational Site 80103
      • Petach-Tikva, Israel
        • Teva Investigational Site 80100
      • RishonLe'zio, Israel
        • Teva Investigational Site 80105
      • Tel-Aviv, Israel
        • Teva Investigational Site 80102
      • Tel-Aviv, Israel
        • Teva Investigational Site 80106
  • United States
    • Alabama
      • Montgomery, Alabama, United States
        • Teva Investigational Site 10007
    • Arizona
      • Phoenix, Arizona, United States
        • Teva Investigational Site 10013
      • Phoenix, Arizona, United States
        • Teva Investigational Site 10017
    • Arkansas
      • Little Rock, Arkansas, United States
        • Teva Investigational Site 10032
    • California
      • San Diego, California, United States
        • Teva Investigational Site 10026
      • San Diego, California, United States
        • Teva Investigational Site 10056
    • Colorado
      • Colorado Springs, Colorado, United States
        • Teva Investigational Site 10002
      • Colorado Springs, Colorado, United States
        • Teva Investigational Site 10033
    • District of Columbia
      • Washington, District of Columbia, United States
        • Teva Investigational Site 10057
    • Florida
      • Clearwater, Florida, United States
        • Teva Investigational Site 10052
      • Jacksonville, Florida, United States
        • Teva Investigational Site 10021
      • Leesburg, Florida, United States
        • Teva Investigational Site 10036
      • Miami, Florida, United States
        • Teva Investigational Site 10012
      • Miami, Florida, United States
        • Teva Investigational Site 10015
      • Palm Beach Gardens, Florida, United States
        • Teva Investigational Site 10055
      • West Palm Beach, Florida, United States
        • Teva Investigational Site 10001
    • Georgia
      • Decatur, Georgia, United States
        • Teva Investigational Site 10031
      • Roswell, Georgia, United States
        • Teva Investigational Site 10041
      • Savannah, Georgia, United States
        • Teva Investigational Site 10050
    • Kentucky
      • Louisville, Kentucky, United States
        • Teva Investigational Site 10008
      • Mount Sterling, Kentucky, United States
        • Teva Investigational Site 10023
    • New Jersey
      • Lawrenceville, New Jersey, United States
        • Teva Investigational Site 10048
      • Moorestown, New Jersey, United States
        • Teva Investigational Site 10030
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Teva Investigational Site 10014
    • New York
      • Rochester, New York, United States
        • Teva Investigational Site 10006
    • North Carolina
      • Cary, North Carolina, United States
        • Teva Investigational Site 10044
      • Charlotte, North Carolina, United States
        • Teva Investigational Site 10040
      • New Bern, North Carolina, United States
        • Teva Investigational Site 10034
      • Winston-Salem, North Carolina, United States
        • Teva Investigational Site 10018
      • Winston-Salem, North Carolina, United States
        • Teva Investigational Site 10046
    • Ohio
      • Columbus, Ohio, United States
        • Teva Investigational Site 10022
      • Columbus, Ohio, United States
        • Teva Investigational Site 10039
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Teva Investigational Site 10028
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Teva Investigational Site 10043
      • Pittsburgh, Pennsylvania, United States
        • Teva Investigational Site 10003
    • South Carolina
      • Bluffton, South Carolina, United States
        • Teva Investigational Site 10049
      • Columbia, South Carolina, United States
        • Teva Investigational Site 10037
      • Greenville, South Carolina, United States
        • Teva Investigational Site 10035
      • Mount Pleasant, South Carolina, United States
        • Teva Investigational Site 10047
    • Tennessee
      • Jackson, Tennessee, United States
        • Teva Investigational Site 10016
      • Knoxville, Tennessee, United States
        • Teva Investigational Site 10045
      • Memphis, Tennessee, United States
        • Teva Investigational Site 10005
      • Nashville, Tennessee, United States
        • Teva Investigational Site 10042
    • Texas
      • Dallas, Texas, United States
        • Teva Investigational Site 10054
      • Houston, Texas, United States
        • Teva Investigational Site 10019
      • San Antonio, Texas, United States
        • Teva Investigational Site 10020
    • Virginia
      • Arlington, Virginia, United States
        • Teva Investigational Site 10038
      • Norfolk, Virginia, United States
        • Teva Investigational Site 10024
      • Norfolk, Virginia, United States
        • Teva Investigational Site 10051
      • Richmond, Virginia, United States
        • Teva Investigational Site 10053
    • Washington
      • Seattle, Washington, United States
        • Teva Investigational Site 10027
      • Tacoma, Washington, United States
        • Teva Investigational Site 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DR-102
desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
Drug: DR-102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: thirteen 28-day cycles
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
thirteen 28-day cycles
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
Time Frame: thirteen 28-day cycles
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
thirteen 28-day cycles
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
Time Frame: thirteen 28-day cycles
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
thirteen 28-day cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Time Frame: thirteen 28-day cycles
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles.
thirteen 28-day cycles
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Time Frame: thirteen 28-day cycles
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
thirteen 28-day cycles
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
Time Frame: thirteen 28-day cycles
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
Time Frame: thirteen 28-day cycles
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
Time Frame: thirteen 28-day cycles
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
thirteen 28-day cycles
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
Time Frame: thirteen 28-day cycles
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
Time Frame: thirteen 28-day cycles
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
Time Frame: thirteen 28-day cycles
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
thirteen 28-day cycles

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Time Frame: 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.
AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event.
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.
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
Time Frame: Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)
A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris.
Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Chair: Teva Women's Health Research Protocol Chair, Teva Women's Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (Estimate)

August 9, 2010

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DSG-PPS-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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