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
Summary
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 ultrasoundSerum levels of FSH, LH, E and P Cervical mucus score Presence of ovarian follicles on transvaginal ultrasound
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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
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