Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

Conditions
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Contraception

Intervention / Treatment
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* Drug: DR-1011


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal Not pregnant or breastfeeding Sexually active at risk of pregnancy Exclusion Criteria: Any contraindication to the use of oral contraceptives Pregnancy within the last 3 months Smoking > 10 cigarettes per day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DR-1011<br>Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles. | Drug: DR-1011<br>* Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).<br>* Other names: levonorgestrel/ethinyl estradiol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | up to one year | 
| 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 | 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) | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Treatment-Emergent Adverse Events | 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. | Day 1 up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy prevention, oral contraceptives