A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Breakthrough Bleeding

Treatments: Drug: Seasonale®; Drug: Portia®; Drug: DR-1031

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394771

DR-ASC-201

Details and patient eligibility

About

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. 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

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Enrollment: 567 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Premenopausal
• Not pregnant or breastfeeding
• Agree to use back-up non-hormonal contraception for study period

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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

567 participants in 4 patient groups

Low Dose DR-1031

Experimental group

Description:

42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.

Treatment:

Drug: DR-1031

Drug: Portia®

Midrange Dose DR-1031

Experimental group

Description:

21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.

Treatment:

Drug: DR-1031

Drug: Portia®

High Dose DR-1031

Experimental group

Description:

21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.

Treatment:

Drug: DR-1031

Drug: Portia®

Seasonale

Active Comparator group

Description:

84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.

Treatment:

Drug: Portia®

Drug: Seasonale®