Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

NCT ID: NCT01941134

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-12-06

Brief 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.

Conditions

Bariatric Surgery Candidate; Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gastric bypass COC

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)

Group Type: EXPERIMENTAL

ethinyl estradiol-levonorgestrel

Intervention Type: DRUG

Women will be asked to take a daily ethinyl estradiol-levonorgestrel combined oral contraceptive (COC) for 21 days, beginning 2-3 months pre-operatively, so as to stop at least 30 days before planned surgery date. Then, approximately 3-4 months after surgery, they will again be asked to take a daily pill for 21 days. During these pill cycles, we will collect serum samples and perform ultrasound and cervical mucus assessments on a twice-weekly basis, culminating in an inpatient stay of up to 48 hours in order to obtain more frequent sampling at the end of the pill pack.

Interventions

ethinyl estradiol-levonorgestrel

Women will be asked to take a daily ethinyl estradiol-levonorgestrel combined oral contraceptive (COC) for 21 days, beginning 2-3 months pre-operatively, so as to stop at least 30 days before planned surgery date. Then, approximately 3-4 months after surgery, they will again be asked to take a daily pill for 21 days. During these pill cycles, we will collect serum samples and perform ultrasound and cervical mucus assessments on a twice-weekly basis, culminating in an inpatient stay of up to 48 hours in order to obtain more frequent sampling at the end of the pill pack.

Intervention Type: DRUG

Other Intervention Names

EE-LNG oral contraceptive

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Burke, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Kimberly Steele, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Roxanne M Jamshidi, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

SFPRF-013-LG

Identifier Type: OTHER

Identifier Source: secondary_id

NA_00009641

Identifier Type: -

Identifier Source: org_study_id