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Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bariatric Surgery Candidate; Contraception

Intervention: ethinyl estradiol-levonorgestrel (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Anne Burke, MD MPH, Principal Investigator, Affiliation: Johns Hopkins University
Kimberly Steele, MD, Principal Investigator, Affiliation: Johns Hopkins University
Roxanne M Jamshidi, MD MPH, Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Anne Burke, MD, Phone: 410-550-0336


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.

Clinical Details

Official title: Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC)

Secondary outcome:

Endometrial thickness on transvaginal ultrasound

Serum levels of FSH, LH, E and P

Cervical mucus score

Presence of ovarian follicles on transvaginal ultrasound


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.


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

Locations and Contacts

Anne Burke, MD, Phone: 410-550-0336

Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States; Recruiting
A Burke, MD, Phone: 410-550-0336
K Steele, MD, Phone: 410-550-0409
Additional Information

Starting date: April 2013
Last updated: March 30, 2015

Page last updated: August 23, 2015

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