Is the blood concentration of an oral contraceptive lower in women who have undergone bariatric surgery compared to non-operated women?

Contraception after gastric bypass - part 4 How does gastric bypass affect the pharmacocinetics of oral levonorgestrel?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004677-17-SE

Enrollment

Registered

2016-01-20

Start date

2016-02-29

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We want to investigate if the pharmacocinetics of levonorgestrel differs in women who have had bariatric surgery compared to women who have not. Measures of serum concentrations of levonorgestrel will be made during 24 hours after intake of Neovletta, containing 0,15 mg levonorgestrel. MedDRA version: 18.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.1 Level: PT Classification code 10061966 Ter

Interventions

Trade Name: Neovletta Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Case: Swedish speaking women age 18-40. History of gastric bypass surgery > one year ago. BMI=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Prior bilateral ooforectomy Pregnancy and/or lactation three months before inclusion Use of Depo-provera twelve months before inclusion other hormonal contraception four weeks before blood sampling Lactose Intolerance Contraindication to Neovletta Daily smoking/intake of nicotine Use of medication as follows: 1. Intake of medicine or substance that is known to inhibit the activity of the enzymes CYP2C9, CYP2C19 and CYP3A4 (according to FDA´s interaction list Table 5) with exception of combined oral contraception for 7 days before clinical trial. 2. Intake of medicine or substance that is known to activate the activity of the enzymes CYP2C9, CYP2C19 and CYP3A4 (according to FDA´s interaction list Table 6) for four weeks before clinical trial. 3. Intake of medicine or substance which a clinical pharmacologist considers potential to interact with the metabolism of levonorgestrel.

Design outcomes

Primary

Measure	Time frame
Main Objective: Gastric bypass is increasing all over the world as one of the most effective treatments of obesity. In Sweden 75% of the operated are women and most of them are still fertile. The operation reduces the volume of the ventricle and by passes a part of the small intestine, which leads to a lack of vitamins and minerals after surgery. How the operation affects the uptake of oral contraceptives is not well studied and we don´t know if these women can be recommended oral contraception. We seek to study if the serum concentration of levonorgestrel after intake of single dose Neovletta differs in women who have had gastric bypass in comparison to women who have not had the surgery. ;Secondary Objective: Not applicable;Primary end point(s): Maximal serumkoncentration and 24-hour AUC (area under the curve) of levonorgestrel;Timepoint(s) of evaluation of this end point: 0-24 hours	—

Measure

Time frame

Main Objective: Gastric bypass is increasing all over the world as one of the most effective treatments of obesity. In Sweden 75% of the operated are women and most of them are still fertile. The operation reduces the volume of the ventricle and by passes a part of the small intestine, which leads to a lack of vitamins and minerals after surgery. How the operation affects the uptake of oral contraceptives is not well studied and we don´t know if these women can be recommended oral contraception. We seek to study if the serum concentration of levonorgestrel after intake of single dose Neovletta differs in women who have had gastric bypass in comparison to women who have not had the surgery. ;Secondary Objective: Not applicable;Primary end point(s): Maximal serumkoncentration and 24-hour AUC (area under the curve) of levonorgestrel;Timepoint(s) of evaluation of this end point: 0-24 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactSekretariat

Kvinnokliniken, Universitetssjukhuset i Linköping

ingela.olsson@regionostergotland.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 27, 2026