Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones

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.

Study Overview

• Status: Withdrawn
• Conditions: Contraception; Bariatric Surgery Candidate
• Intervention / Treatment: Drug: ethinyl estradiol-levonorgestrel

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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)

Drug: 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.; Other Names: EE-LNG oral contraceptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC)	twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness on transvaginal ultrasound		twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Serum levels of FSH, LH, E and P	Serum levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), estradiol (E) and progesterone (P)	twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Cervical mucus score	We will assess cervical mucus favorability according to standard criteria.	twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Presence of ovarian follicles on transvaginal ultrasound	We will assess for and measure ovarian follicles with maximum diameter 10mm or greater	twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Anne Burke, MD MPH, Johns Hopkins University; Principal Investigator: Kimberly Steele, MD, Johns Hopkins University; Principal Investigator: Roxanne M Jamshidi, MD MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 6, 2017
• Study Completion (Actual): December 6, 2017

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Estradiol; Contraceptive Agents; Ethinyl Estradiol; Contraceptives, Oral; Ethinyl estradiol, levonorgestrel drug combination
• Other Study ID Numbers: NA_00009641; SFPRF-013-LG (Other Identifier: Society for Family Planning)