NCT00745901

Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females

An Open Label Study to Evaluate Cycle Control With Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) and Yaz (Drospirenone/Ethinyl Estradiol) in Healthy Sexually Active Females

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.

Detailed description

This is a randomized, open-label, active-controlled, multicenter study in healthy sexually active females to evaluate cycle control with norgestimate/ethinyl estradiol versus drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day cycles. Approximately 300 patients will be randomized in a 1:1 fashion according to a predetermined randomization schedule. Patients will be seen for a baseline visit (Visit 1) up to 35 days prior to dosing to obtain informed consent, have a physical examination including a breast exam, height and weight, vital signs, a Chlamydia test and a urine pregnancy test performed, and to give their medical history. Patients will be instructed to report bleeding data using an interactive voice response system (IVRS) based diary on a daily basis. Patients will be instructed to continue taking 1 pill each day for 3 cycles, record this information daily in the IVRS and to contact the study site if they have any questions or adverse events they would like to discuss. The final study visit (Visit 2) will occur on Day 8 after completing 3 cycles of study medication. Patients will be weighed, have vital signs performed, report any adverse events and or changes in concomitant medications, and complete the satisfaction questionnaire at the final visit. Safety will be assessed by physical examinations, adverse events, body weight and vital signs. Patients randomized to drospireneone/ethinyl estradiol and taking any medication that could increase serum potassium levels (as outlined in the Package Insert) will also have their potassium level checked during their first cycle of treatment (Days 15 to 28 of treatment). Three 28-day cycles of either norgestimate/ethinyl estradiol or drospirenone/ethinyl estradiol.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-09-03
• Last updated: 2019-03-19
• Results posted: 2010-05-25