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Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

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ClinicalTrials.gov Identifier: NCT01941134
Recruitment Status : Withdrawn (Recruitment trouble)
First Posted : September 13, 2013
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Contraception Drug: ethinyl estradiol-levonorgestrel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones
Actual Study Start Date : April 2013
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017


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 Name: EE-LNG oral contraceptive



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
    Serum levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), estradiol (E) and progesterone (P)

  3. 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 ]
    We will assess cervical mucus favorability according to standard criteria.

  4. 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 ]
    We will assess for and measure ovarian follicles with maximum diameter 10mm or greater



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941134


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
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
Principal Investigator: Roxanne M Jamshidi, MD MPH Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01941134     History of Changes
Other Study ID Numbers: NA_00009641
SFPRF-013-LG ( Other Identifier: Society for Family Planning )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

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