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

NCT01178125 | Completed Phase 3 Results

• 1 other identifier: DSG-PPS-303
• Study Type: interventional
• Target: 2,858
• Locations: 2 countries
• Sites: 62

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.

Conditions

Contraception; Female Contraception

Keywords

Pregnancy Prevention; Oral Contraceptives

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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 Outcomes (8)

• All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight

  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

  thirteen 28-day cycles

• Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule

  thirteen 28-day cycles

• Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule

  thirteen 28-day cycles

• Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule

  thirteen 28-day cycles

Other Outcomes (2)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs

  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

  Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)

Study Arms (1)

DR-102

EXPERIMENTAL

desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days

Drug: DR-102

Interventions

DR-102 DRUG

DR-102

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (62)

Teva Investigational Site 10007

Montgomery, Alabama, United States

Location

Teva Investigational Site 10013

Phoenix, Arizona, United States

Location

Teva Investigational Site 10017

Phoenix, Arizona, United States

Location

Teva Investigational Site 10032

Little Rock, Arkansas, United States

Location

Teva Investigational Site 10026

San Diego, California, United States

Location

Teva Investigational Site 10056

San Diego, California, United States

Location

Teva Investigational Site 10002

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 10033

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 10057

Washington D.C., District of Columbia, United States

Location

Teva Investigational Site 10052

Clearwater, Florida, United States

Location

Teva Investigational Site 10021

Jacksonville, Florida, United States

Location

Teva Investigational Site 10036

Leesburg, Florida, United States

Location

Teva Investigational Site 10012

Miami, Florida, United States

Location

Teva Investigational Site 10015

Miami, Florida, United States

Location

Teva Investigational Site 10055

Palm Beach Gardens, Florida, United States

Location

Teva Investigational Site 10001

West Palm Beach, Florida, United States

Location

Teva Investigational Site 10031

Decatur, Georgia, United States

Location

Teva Investigational Site 10041

Roswell, Georgia, United States

Location

Teva Investigational Site 10050

Savannah, Georgia, United States

Location

Teva Investigational Site 10008

Louisville, Kentucky, United States

Location

Teva Investigational Site 10023

Mount Sterling, Kentucky, United States

Location

Teva Investigational Site 10048

Lawrenceville, New Jersey, United States

Location

Teva Investigational Site 10030

Moorestown, New Jersey, United States

Location

Teva Investigational Site 10014

Albuquerque, New Mexico, United States

Location

Teva Investigational Site 10006

Rochester, New York, United States

Location

Teva Investigational Site 10044

Cary, North Carolina, United States

Location

Teva Investigational Site 10040

Charlotte, North Carolina, United States

Location

Teva Investigational Site 10034

New Bern, North Carolina, United States

Location

Teva Investigational Site 10018

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 10046

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 10022

Columbus, Ohio, United States

Location

Teva Investigational Site 10039

Columbus, Ohio, United States

Location

Teva Investigational Site 10028

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10043

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 10003

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 10049

Bluffton, South Carolina, United States

Location

Teva Investigational Site 10037

Columbia, South Carolina, United States

Location

Teva Investigational Site 10035

Greenville, South Carolina, United States

Location

Teva Investigational Site 10047

Mt. Pleasant, South Carolina, United States

Location

Teva Investigational Site 10016

Jackson, Tennessee, United States

Location

Teva Investigational Site 10045

Knoxville, Tennessee, United States

Location

Teva Investigational Site 10005

Memphis, Tennessee, United States

Location

Teva Investigational Site 10042

Nashville, Tennessee, United States

Location

Teva Investigational Site 10054

Dallas, Texas, United States

Location

Teva Investigational Site 10019

Houston, Texas, United States

Location

Teva Investigational Site 10020

San Antonio, Texas, United States

Location

Teva Investigational Site 10038

Arlington, Virginia, United States

Location

Teva Investigational Site 10024

Norfolk, Virginia, United States

Location

Teva Investigational Site 10051

Norfolk, Virginia, United States

Location

Teva Investigational Site 10053

Richmond, Virginia, United States

Location

Teva Investigational Site 10027

Seattle, Washington, United States

Location

Teva Investigational Site 10029

Tacoma, Washington, United States

Location

Teva Investigational Site 80108

Beersheba, Israel

Location

Teva Investigational Site 80109

Giv‘atayim, Israel

Location

Teva Investigational Site 80104

Haifa, Israel

Location

Teva Investigational Site 80107

Haifa, Israel

Location

Teva Investigational Site 80101

Modiin, Israel

Location

Teva Investigational Site 80103

Or Yehuda, Israel

Location

Teva Investigational Site 80100

Petah Tikva, Israel

Location

Teva Investigational Site 80105

RishonLe'zio, Israel

Location

Teva Investigational Site 80102

Tel Aviv, Israel

Location

Teva Investigational Site 80106

Tel Aviv, Israel

Location

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Teva Women's Health Research Protocol Chair

  Teva Women's Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 9, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 9, 2021
• Results First Posted: December 11, 2013

Record last verified: 2021-11

Locations

US (52); IL (10)