Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

Johns Hopkins University

Status and phase: Withdrawn; Phase 4

Conditions: Contraception; Bariatric Surgery Candidate

Treatments: Drug: ethinyl estradiol-levonorgestrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01941134

SFPRF-013-LG (Other Identifier)

NA_00009641

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Gastric bypass COC

Experimental group

Description:

This is a before-and-after comparison. Women will enroll prior to planned gastric bypass surgery and complete one cycle of oral contraceptive use and evaluation. There will then be no more study procedures/interventions until 3-4 months after surgery. At that time, women will complete the second cycle of OC use and evaluation. Study participation is then complete. Intervention: Ethinyl estradiol-levonorgestrel(EE 20mcg/LNG 150mcg)

Treatment:

Drug: ethinyl estradiol-levonorgestrel