Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

This study is currently recruiting participants.
Verified September 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Anne Burke, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01941134
First received: June 12, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Bariatric Surgery Candidate
Contraception
Drug: ethinyl estradiol-levonorgestrel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endometrial thickness on transvaginal ultrasound [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Serum levels of FSH, LH, E and P [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Serum levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), estradiol (E) and progesterone (P)

  • Cervical mucus score [ Time Frame: 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 ] [ Designated as safety issue: No ]
    We will assess cervical mucus favorability according to standard criteria.

  • Presence of ovarian follicles on transvaginal ultrasound [ Time Frame: 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 ] [ Designated as safety issue: No ]
    We will assess for and measure ovarian follicles with maximum diameter 10mm or greater


Estimated Enrollment: 16
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EE-LNG oral contraceptive

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941134

Contacts
Contact: Anne Burke, MD 410-550-0336

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: A Burke, MD    410-550-0336      
Contact: K Steele, MD    410-550-0409      
Sponsors and Collaborators
Johns Hopkins University
Society of Family Planning
Investigators
Principal Investigator: Anne Burke, MD MPH Johns Hopkins University
Principal Investigator: Kimberly Steele, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Anne Burke, Associate Professor, Gyn/OB, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01941134     History of Changes
Other Study ID Numbers: SFPRF-013-LG
Study First Received: June 12, 2013
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Hormones
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on April 17, 2014