Evaluation of Hormonal Contraceptive Treatments in Obese Women (OBECO)

August 10, 2018 updated by: Assistance Publique - Hôpitaux de Paris

Pharmacological Evaluation of Hormonal Contraceptive Treatments in Obese Women Before and After Bariatric Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Open, multi-center pharmacological study of residual concentrations of three different oral contraceptives in 3 groups of obese women in each group of surgery, and 1 group of healthy volunteers. The concentrations will be assessed before, 6 and 12 months after bariatric surgery restrictive (sleeve gastrectomy) or malabsorptive (gastric by pass).

Contraception is an important issue in women with obesity. There are actually few data answering the questions of the efficacy of oral contraceptive in obese women, as this condition could be a risk factor for failure of hormonal contraception, due to the changes in drug metabolism and a larger volume of distribution in obesity. Bariatric surgery is the most efficient therapeutic for weight loss in severe and morbid obesity. In 2011, more than 31 000 bariatric procedures have been performed in France with sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB) representing the two most frequent procedures. Women represent 80 % of surgical patients and most of them are in childbearing age (mean age of 39 years). Obese women who receive surgical treatment for obesity are advised not to conceive for the following 12 to 18 months, both to ensure optimal weight loss and a stable weight during pregnancy, and also to begin pregnancy with optimal nutritional and vitamin status. There are no data on the changes in oral contraceptives concentrations before and after bariatric surgery, as malabsorption and anatomic digestive modifications following surgery may theoretically affect bioavailability.

Primary Objective :

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 ethinyl E2 and levonorgestrel and a progestin contraceptive desogestrel).

Secondary Objectives :

  • To assess if the difference of Css before, 6 months and 12 months after surgery is the same in the 3 groups of oral contraceptives and in the 2 groups of surgery
  • To compare the Css of obese women before, 6 months and 12 months after surgery to T0 Css of normal-weight patients for each group of oral contraceptive
  • To assess the impact of oral contraceptives on gonadotroph axis, hemostatic variables and estrogen-sensitive protein in obese women before and 6 and 12 months after surgery and in normal-weight women
  • Analyze of correlation between body composition, nutritional status and Css in the 3 groups of oral contraceptives and in the 2 groups of bariatric surgery

Secondary End Points:

  • Css of oral contraceptive agent 12 months after bariatric surgery
  • Css of oral contraceptive agent in normal weight women
  • Sequential Body composition by DXA and Impedancemetry before and 6 months and 12 months after surgery.
  • Nutritional status in obese women before and after surgery (albumin, prealbuminemia, RBP, transferrin, haemoglobin, lipid (total cholesterol, triglycerides, LDL and HDL)
  • Evaluation of gonadotroph axis by hormonal assays: FSH, LH, estradiol, AMH, progesterone, testosterone total, Inhibin B in normal-weight women and obese women before and 6 months and 12 months after surgery
  • Evaluation of hemostatic variables (protein S, APC) and SHBG in normal-weight women and obese women before and 6 months and 12 months after surgery
  • Number of unexpected pregnancies occurred during the study

Study Type

Observational

Enrollment (Anticipated)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France
        • Recruiting
        • Hôpital Ambroise Paré
      • Paris, France, 75013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Eligibility Criteria:

Inclusion criteria :

  • 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

Exclusion criteria :

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese women SG
Obese women operated by sleeve gastrectomy
Other: Blood samples for measurement of drug Css
Blood samples for measurement of drug Css
Other: DXA and impedancemetry
Body composition by DXA and impedancemetry
Normal weight women
Other: Blood samples for measurement of drug Css
Blood samples for measurement of drug Css
Other: DXA and impedancemetry
Body composition by DXA and impedancemetry
Obese women GBP
Obese women operated by Rougastric bypass
Other: Blood samples for measurement of drug Css
Blood samples for measurement of drug Css
Other: DXA and impedancemetry
Body composition by DXA and impedancemetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Css
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Css
Time Frame: 12 months
• To assess if the difference of Css before, 6 months and 12 months after surgery is the same in the 3 groups of oral contraceptives and in the 2 groups of surgery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Anne Bachelot, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 130942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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