Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to assess hormone withdrawal symptoms in women while taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in comparison to taking pills in the standard 21/7 (21 "real" pills) manner.

It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms compared to the standard 21/7 regimen.

It is further hypothesized that women using the 24/4 regimen will report greater satisfaction scores.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scott and White Hospital & Clinic
• Collaborator: Warner Chilcott
• Treatments: Mestranol; Norethindrone; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl

Criteria

Inclusion Criteria:

• current users (>2 months) of a combination hormonal contraceptive (OC, contraceptive ring, contraceptive patch) with at least the most recent cycle ending with a 7 day HFI

• age 18-48

• BMI of 40 or less

• not desiring to become pregnant during the study time (about 8 months)

• capable and reliable in regards to recording and maintaining a daily symptoms log

Exclusion Criteria:

• a condition which will not allow you to use combination hormonal contraception; including a past or present history of diabetes, high blood pressure, stroke, breast cancer, heart attacks, blood clots, liver disease, or systemic lupus erythematosus.

• are pregnant or plan to become pregnant in the next 8 months or while you are in the study.

• a smoker greater than or equal to 35 years of age. You smoke 10 or more cigarettes a day and you are under the age of 35.