Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

Withdrawn before enrolling · Phase 4

Conditions studied: Bariatric Surgery Candidate, Contraception

In brief

This study will attempt to determine whether having gastric bypass surgery changes the way that the gut absorbs hormones from birth control pills. It is believed that, because gastric bypass surgery causes malabsorption of nutrients and some medications, the levels of birth control hormones after the surgery will be lower than in women before they have the surgery. The investigators will ask several women to take a pack of birth control pills before having bypass surgery, and then another pack several months after surgery. The investigators will measure hormone levels in the blood. The investigators will also measure outcomes that may tell us how well the birth control pills are working, such as ultrasounds of the uterus and ovaries, and examination of the cervix.

Key facts

Study ID

NCT01941134

Run by

Johns Hopkins University

People needed

0

Starts

2013-04-01

Expected to finish

2017-12-06

Last updated by the study team

2018-03-21

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Planning to undergo gastric bypass surgery at our institution
• willing to take 2 monthly cycles of the oral contraceptive: one cycle before and one after surgery
• use of Depo-provera within 6 months of enrollment
• Use of implantable or intrauterine contraception
• able to attend multiple study visits

You may not qualify if…

• Any contraindication to combined hormonal contraceptive use
• Surgical complications precluding further participation

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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