A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Contraception; Female Contraception

Treatments: Drug: DR-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01178125

DSG-PPS-303

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-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.

Enrollment: 2,858 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 oral contraceptive 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 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 greater than or equal to 35 years
• Others as dictated by protocol

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,858 participants in 1 patient group

DR-102

Experimental group

Description:

desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days

Treatment:

Drug: DR-102