NCT02398903|Unknown
Evaluation of Hormonal Contraceptive Treatments in Obese Women
OBECO
Pharmacological Evaluation of Hormonal Contraceptive Treatments in Obese Women Before and After Bariatric Surgery
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OBECO
Pharmacological Evaluation of Hormonal Contraceptive Treatments in Obese Women Before and After Bariatric Surgery
Sponsor study identifier
observational
174
1 country
2
Study Start
March 16, 2015
Actual (reported)Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2015
Actual (reported)March 16, 2015
Actual (reported)March 26, 2015
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Css
12 months
Obese women operated by sleeve gastrectomy
Normal weight women
Obese women operated by Rougastric bypass
Blood samples for measurement of drug Css
Body composition by DXA and impedancemetry
Obese women with an indication of bariatric surgery by RYGB or sleeve gastrectomy under oral contraceptive treatment. Normal-weight women under oral contraceptive treatment.
Hôpital Ambroise Paré
Boulogne-Billancourt, France
Pitié Salpetriere Hospital
Paris, 75013, France
Blood samples for measurement of drug Css
Anne Bachelot, MD, PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
February 9, 2015
First Posted
March 26, 2015
Study Start
March 16, 2015
Actual (reported)Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Impact of the Use of VERT on Body Image After Bariatric Surgery
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Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 13, 2018
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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