A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196352

PSE-304

Details and patient eligibility

About

This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

Full description

This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.

Enrollment: 320 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion criteria

• Any contraindication to the use of oral contraceptives

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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320 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets