Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

NCT01941134 | Withdrawn Phase 4

• 2 other identifiers: NA_00009641SFPRF-013-LG
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  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

  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

Study Arms (1)

Gastric bypass COC

EXPERIMENTAL

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

Interventions

ethinyl estradiol-levonorgestrel 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.

Also known as: EE-LNG oral contraceptive

Gastric bypass COC

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: September 13, 2013
• Study Start: April 1, 2013
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

US (1)