NCT02398903

Brief Summary

The aim of our study is to assess the concentrations of different oral contraceptive agents in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve gastrectomy) in order to study the role of the surgery and the role of body weight on drug concentrations, and to compare these concentrations with those of normal-weight women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 13, 2018

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

February 9, 2015

Last Update Submit

August 10, 2018

Conditions

ObesityBariatric Surgery CandidateOral Contraceptive

Keywords

Morbid obesitybariatric surgerysleeve gastrectomyRoux-en-Y gastric bypasshormonal contraceptioncombined oral contraceptiveprogestin contraceptive desogestrelpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Css

    The difference between Css before bariatric surgery and 6 months after the surgery in obese women regardless of the oral contraceptives used. Three different oral contraceptives are employed (two combined oral contraceptive containing ethynil E2 and levonorgestrel and a progestin contraceptive desogestrel).

    6 months

Secondary Outcomes (1)

  • Css

    12 months

Study Arms (3)

Obese women SG

Obese women operated by sleeve gastrectomy

Other: Blood samples for measurement of drug CssOther: DXA and impedancemetry

Normal weight women

Normal weight women

Other: Blood samples for measurement of drug CssOther: DXA and impedancemetry

Obese women GBP

Obese women operated by Rougastric bypass

Other: Blood samples for measurement of drug CssOther: DXA and impedancemetry

Interventions

Blood samples for measurement of drug CssOTHER

Blood samples for measurement of drug Css

Normal weight womenObese women GBPObese women SG
DXA and impedancemetryOTHER

Body composition by DXA and impedancemetry

Normal weight womenObese women GBPObese women SG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese women with an indication of bariatric surgery by RYGB or sleeve gastrectomy under oral contraceptive treatment. Normal-weight women under oral contraceptive treatment.

You may qualify if:

  • Obese women
  • Obese women (BMI ≥ 35 kg/m² with obesity related comorbidity or BMI ≥ 40 kg/m²) with an indication of bariatric surgery by RYGB or sleeve gastrectomy under oral contraceptive treatment of interest in our study
  • Aged 18 to 45 years if desogestrel or 18 to 35 years if COC
  • Signed informed consent
  • Affiliated to The French Social Security Health insurance
  • Healthy Volunteers
  • Normal weight (BMI \< 25 kg/m²)
  • Women under oral contraceptive treatment
  • Aged 18 to 45 years
  • Signed informed consent
  • Affiliated to The French Social Security Health insurance

You may not qualify if:

  • Drug treatment known to interact with cytochrome P450 (CYP3A4).
  • Contraindication for an oral contraceptive agent as mentioned in the summary of product characteristics
  • Positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Ambroise Paré

Boulogne-Billancourt, France

RECRUITING

Pitié Salpetriere Hospital

Paris, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for measurement of drug Css

MeSH Terms

Conditions

ObesityObesity, Morbid

Interventions

Blood Specimen CollectionAbsorptiometry, Photon

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesRadiographyDiagnostic ImagingDensitometryPhotometryChemistry Techniques, Analytical

Study Officials

  • Anne Bachelot, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Bachelot, MD, PhD

CONTACT

+33 1 42 16 02 46anne.bachelot@psl.aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 26, 2015

Study Start

March 16, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 13, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)