Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01941134
• Other study ID #: NA_00009641
• Secondary ID: SFPRF-013-LG
• Status: Withdrawn
• Phase: Phase 4
• First received: June 12, 2013
• Last updated: March 19, 2018
• Start date: April 2013
• Est. completion date: December 6, 2017

Study information

• Verified date: March 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 6, 2017
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Contraception

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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