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ContraceptionPhase 3NCT01178125

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

A Phase 3 study testing DR-102 in people with Contraception and Female Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception, Female Contraception
What is being tested?
DR-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,858 participants
Where
62 sitesin 2 countries
Study dates
Aug 2010to Jan 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States52 sites

  • Teva Investigational Site 10014

    Albuquerque, New Mexico

  • Teva Investigational Site 10038

    Arlington, Virginia

  • Teva Investigational Site 10049

    Bluffton, South Carolina

  • Teva Investigational Site 10044

    Cary, North Carolina

  • Teva Investigational Site 10040

    Charlotte, North Carolina

  • Teva Investigational Site 10052

    Clearwater, Florida

  • Teva Investigational Site 10002

    Colorado Springs, Colorado

  • Teva Investigational Site 10033

    Colorado Springs, Colorado

  • Teva Investigational Site 10037

    Columbia, South Carolina

  • Teva Investigational Site 10022

    Columbus, Ohio

  • Teva Investigational Site 10039

    Columbus, Ohio

  • Teva Investigational Site 10054

    Dallas, Texas

  • Teva Investigational Site 10031

    Decatur, Georgia

  • Teva Investigational Site 10035

    Greenville, South Carolina

  • Teva Investigational Site 10019

    Houston, Texas

  • Teva Investigational Site 10016

    Jackson, Tennessee

  • Teva Investigational Site 10021

    Jacksonville, Florida

  • Teva Investigational Site 10045

    Knoxville, Tennessee

  • Teva Investigational Site 10048

    Lawrenceville, New Jersey

  • Teva Investigational Site 10036

    Leesburg, Florida

  • Teva Investigational Site 10032

    Little Rock, Arkansas

  • Teva Investigational Site 10008

    Louisville, Kentucky

  • Teva Investigational Site 10005

    Memphis, Tennessee

  • Teva Investigational Site 10012

    Miami, Florida

  • Teva Investigational Site 10015

    Miami, Florida

  • Teva Investigational Site 10007

    Montgomery, Alabama

  • Teva Investigational Site 10030

    Moorestown, New Jersey

  • Teva Investigational Site 10023

    Mount Sterling, Kentucky

  • Teva Investigational Site 10047

    Mt. Pleasant, South Carolina

  • Teva Investigational Site 10042

    Nashville, Tennessee

  • Teva Investigational Site 10034

    New Bern, North Carolina

  • Teva Investigational Site 10024

    Norfolk, Virginia

  • Teva Investigational Site 10051

    Norfolk, Virginia

  • Teva Investigational Site 10028

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10055

    Palm Beach Gardens, Florida

  • Teva Investigational Site 10043

    Philadelphia, Pennsylvania

  • Teva Investigational Site 10013

    Phoenix, Arizona

  • Teva Investigational Site 10017

    Phoenix, Arizona

  • Teva Investigational Site 10003

    Pittsburgh, Pennsylvania

  • Teva Investigational Site 10053

    Richmond, Virginia

  • Teva Investigational Site 10006

    Rochester, New York

  • Teva Investigational Site 10041

    Roswell, Georgia

  • Teva Investigational Site 10020

    San Antonio, Texas

  • Teva Investigational Site 10026

    San Diego, California

  • Teva Investigational Site 10056

    San Diego, California

  • Teva Investigational Site 10050

    Savannah, Georgia

  • Teva Investigational Site 10027

    Seattle, Washington

  • Teva Investigational Site 10029

    Tacoma, Washington

  • Teva Investigational Site 10057

    Washington D.C., District of Columbia

  • Teva Investigational Site 10001

    West Palm Beach, Florida

  • Teva Investigational Site 10018

    Winston-Salem, North Carolina

  • Teva Investigational Site 10046

    Winston-Salem, North Carolina

Other trials in United States

Israel10 sites

  • Teva Investigational Site 80108

    Beersheba

  • Teva Investigational Site 80109

    Giv‘atayim

  • Teva Investigational Site 80104

    Haifa

  • Teva Investigational Site 80107

    Haifa

  • Teva Investigational Site 80101

    Modiin

  • Teva Investigational Site 80103

    Or Yehuda

  • Teva Investigational Site 80100

    Petah Tikva

  • Teva Investigational Site 80105

    RishonLe'zio

  • Teva Investigational Site 80102

    Tel Aviv

  • Teva Investigational Site 80106

    Tel Aviv

Other trials in Israel

About this study

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

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.

Being tested
DR-102
Keywords
Pregnancy Prevention, Oral Contraceptives

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DR-102Drug

Study groups in NCT01178125
Study groupRoleWhat they receive
DR-102Experimentaldesogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
Receives: Drug: DR-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: thirteen 28-day cycles

  2. 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.

    Measured: thirteen 28-day cycles

  3. 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.

    Measured: thirteen 28-day cycles

Secondary outcomes (8)

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

    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.

    Measured: thirteen 28-day cycles

  2. Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight

    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.

    Measured: thirteen 28-day cycles

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

    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.

    Measured: thirteen 28-day cycles

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

    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.

    Measured: thirteen 28-day cycles

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

    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.

    Measured: thirteen 28-day cycles

  6. Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule

    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.

    Measured: thirteen 28-day cycles

  7. Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule

    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.

    Measured: thirteen 28-day cycles

  8. Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule

    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.

    Measured: thirteen 28-day cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,858 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01178125
Sponsor's protocol ID
DSG-PPS-303
Status last verified
Nov 2021
First submitted
6 Aug 2010
Last updated
9 Nov 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DR-102 in people with Contraception and Female Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 62 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: thirteen 28-day cycles). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01178125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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