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

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: DR-1011

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196326

DR-PSE-309

Details and patient eligibility

About

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.

Enrollment: 2,235 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,235 participants in 1 patient group

DR-1011

Experimental group

Description:

Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.

Treatment:

Drug: DR-1011