A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pregnancy Prevention

Treatments: Drug: DR-103

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996580

DR-103-301

Details and patient eligibility

About

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Enrollment: 3,597 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sexually active at risk for pregnancy
• Agreement to use study OC 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 FDA-approved protocol

Exclusion criteria

• Any contraindication to the use of oral contraceptives
• Pregnancy or plans to become pregnant in the next 14 months
• Smoker and age ≥ 35 years
• Others as dictated by FDA-approved protocol

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,597 participants in 1 patient group

DR-103

Experimental group

Description:

Four 91-day cycles of the DR-103 regimen: * 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; * 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; * 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; * 7 days of 10 mcg EE.

Treatment:

Drug: DR-103