Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: DR-1021

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362479

DR-DSG-301

Details and patient eligibility

About

This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Full description

The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

Enrollment: 1,347 patients

Sex: Female

Ages: 18 to 45 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,347 participants in 1 patient group

1

Experimental group

Treatment:

Drug: DR-1021