Clinical trial NCT01941134: Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery
Official title: Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Contraception
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2013-09-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC)
timeFrame: 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:
measure: Endometrial thickness on transvaginal ultrasound
timeFrame: 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
measure: Serum levels of FSH, LH, E and P
timeFrame: 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
measure: Cervical mucus score
timeFrame: 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
measure: Presence of ovarian follicles on transvaginal ultrasound
timeFrame: 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
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anne Burke, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Kimberly Steele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Roxanne M Jamshidi, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: