ObesityOBECONCT02398903
Evaluation of Hormonal Contraceptive Treatments in Obese Women
An observational study of Obesity and Bariatric Surgery Candidate, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Oral Contraceptive
- What is being tested?
- Blood samples for measurement of drug Css and DXA and impedancemetry
- How many people
- 174 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Mar 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital Ambroise Paré
Boulogne-Billancourt
- Recruiting
Pitié Salpetriere Hospital
Paris, 75013
Anne Bachelot, MD, PhD, anne.bachelot@psl.aphp.fr
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity, Bariatric Surgery Candidate, Oral Contraceptive
- Being tested
- Blood samples for measurement of drug Css, DXA and impedancemetry
- Keywords
- Morbid obesity, bariatric surgery, sleeve gastrectomy, Roux-en-Y gastric bypass, hormonal contraception, combined oral contraceptive, progestin contraceptive desogestrel, pharmacokinetics
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for measurement of drug CssOther
Blood samples for measurement of drug Css
DXA and impedancemetryOther
Body composition by DXA and impedancemetry
| Study group | Role | What they receive |
|---|---|---|
| Obese women SG | Obese women operated by sleeve gastrectomy Receives: Other: Blood samples for measurement of drug Css; Other: DXA and impedancemetry | |
| Normal weight women | Normal weight women Receives: Other: Blood samples for measurement of drug Css; Other: DXA and impedancemetry | |
| Obese women GBP | Obese women operated by Rougastric bypass Receives: Other: Blood samples for measurement of drug Css; Other: DXA and impedancemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
Css
- 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study start16 Mar 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Bachelot, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398903
- Sponsor's protocol ID
- P 130942
- Acronym
- OBECO
- Status last verified
- Oct 2017
- First submitted
- 9 Feb 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Evaluation of Hormonal Contraceptive Treatments in Obese Women Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02398903
- Acronym / sponsor ID
- OBECO / P 130942
- Conditions
- Obesity, Bariatric Surgery Candidate, Oral Contraceptive
- Keywords
- Morbid obesity, bariatric surgery, sleeve gastrectomy, Roux-en-Y gastric bypass, hormonal contraception, combined oral contraceptive, progestin contraceptive desogestrel, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese women SG | – | Other: Blood samples for measurement of drug Css, Other: DXA and impedancemetryObese women operated by sleeve gastrectomy |
| Normal weight women | – | Other: Blood samples for measurement of drug Css, Other: DXA and impedancemetryNormal weight women |
| Obese women GBP | – | Other: Blood samples for measurement of drug Css, Other: DXA and impedancemetryObese women operated by Rougastric bypass |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (11 listed)
- Obese women
- Healthy Volunteers
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for measurement of drug CssBlood samples for measurement of drug Css | Other | Normal weight women, Obese women GBP, Obese women SG |
| DXA and impedancemetryBody composition by DXA and impedancemetry | Other | Normal weight women, Obese women GBP, Obese women SG |
Primary outcome
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).
1 secondary outcome
Css
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Bachelot, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery Candidate, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Bachelot, MD, PhD (+33 1 42 16 02 46, anne.bachelot@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Css (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.