Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
- Registration Number
- NCT00196326
- Lead Sponsor
- Duramed Research
- Brief Summary
This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2235
- Premenopausal
- Not pregnant or breastfeeding
- Sexually active at risk of pregnancy
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking > 10 cigarettes per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DR-1011 DR-1011 Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
- Primary Outcome Measures
Name Time Method Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy up to one year Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed.
The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.
Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.
Three denominators are reported;
* excluding cycles where other birth control methods (BCMs) was used
* all complete cycles
* compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy up to one year Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed.
The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.
Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.
Three denominators are reported;
* excluding cycles where other birth control methods (BCMs) was used
* all complete cycles
* compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
- Secondary Outcome Measures
Name Time Method Participants With Treatment-Emergent Adverse Events Day 1 up to one year Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.
Trial Locations
- Locations (1)
Duramed Investigational Site
🇺🇸Tacoma, Washington, United States