Bariatric Surgery Candidate, Contraception
Conditions
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.
Interventions
DRUGethinyl 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.
Sponsors
Society of Family Planning
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Serum levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), estradiol (E) and progesterone (P) |
| 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 | We will assess cervical mucus favorability according to standard criteria. |
| 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 | We will assess for and measure ovarian follicles with maximum diameter 10mm or greater |
Countries
United States
Outcome results
None listed