Is the effectiveness of oral contraception affected by gastric bypass?

Contraception after gastric bypass - part three How does gastric bypass affect the pharmacocinetics of oral desogestrel?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005797-58-SE

Enrollment

Registered

2013-02-19

Start date

2013-04-19

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 how the pharmacocinetics changes for Cerazette in 14 fertile obese women after, compared to before, bariatric surgery in forms of gastric by pass. Mesures of serum concetrations of desogestrel (the active metabolite of Cerazette) will be made in the same women 3 months before and 3 and 12 months after surgery. The women selected for the trial will all ready be users of Cerazette. MedDRA version: 14.1 Level: PT Classification code 10030970 Term: Oral contraception System

Interventions

Trade Name: Cerazette Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women age 18- 45 Accepted to undergo gastric bypass All ready using Cerazette Speaks Swedish fluently Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Prior hysterectomy 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 inclusion Undiagnosed vaginal bleeding Low calorie diet Use of anti epileptic drugs, use of rifampicin, use of St John´s wort Lactose intolerance Contraindication to Cerazette Smoking

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, even so in Sweden. Here 75% of the operated are women and most of them are still fertile. They are recommended not to become pregnant for at least 12 months after surgery. The operation reduces the volume of the ventricle and by passes a part of the small intestine, wich leads to a lack of vitamins and minerals after surgery. How the operation affects the uptake of oral contraceptives are not studied and we don´t know if these women can be recommended oral contraceptives after surgery. We seek to study the changes in maximal serum concentration of the actvie metabolite of the progestine only pill, Cerazette 3 months before, 3 months after and 12 months after surgery. ;Secondary Objective: not applicable;Primary end point(s): Does gastric bypass surgery affect the serum concentration of etonogestrel measured as maximal plasma concentration (Area Under the Curve - AUC)?;Timepoint(s) of evaluation of this end point: After all the measurements of all the participants have been made	—

Measure

Time frame

Main Objective: Gastric bypass is increasing all over the world as one of the most effective treatments of obesity, even so in Sweden. Here 75% of the operated are women and most of them are still fertile. They are recommended not to become pregnant for at least 12 months after surgery. The operation reduces the volume of the ventricle and by passes a part of the small intestine, wich leads to a lack of vitamins and minerals after surgery. How the operation affects the uptake of oral contraceptives are not studied and we don´t know if these women can be recommended oral contraceptives after surgery. We seek to study the changes in maximal serum concentration of the actvie metabolite of the progestine only pill, Cerazette 3 months before, 3 months after and 12 months after surgery. ;Secondary Objective: not applicable;Primary end point(s): Does gastric bypass surgery affect the serum concentration of etonogestrel measured as maximal plasma concentration (Area Under the Curve - AUC)?;Timepoint(s) of evaluation of this end point: After all the measurements of all the participants have been made

—

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, Universitetsjukhuset i Linköping

ingela.olsson@lio.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026