Obesity Clinical Trial
Official title:
Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
NCT number | NCT02104609 |
Other study ID # | HS-12-00602 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | May 2016 |
Verified date | April 2019 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to determine the effects of obesity on the pharmacokinetics of
the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of
ovulation
Primary hypothesis:
1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger
volume of distribution of LNG.
Secondary hypothesis:
1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women
affect the primary mechanism of action, which is inhibition of ovulation.
2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding
globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free
LNG.
Status | Completed |
Enrollment | 26 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Women between ages 18-35 years - Regular menstrual cycles (24-35 days) for the past 2 months - Ovulatory at defined by midluteal progesterone level >3 ng/mL (Day 18-25) - Belongs to one of the following categories: normal weight (BMI = 18.5-24.9 kg/m2), obese (BMI = 30-39.9 kg/m2) or extremely obese (BMI = 40 kg/m2) - Participant has no intention of or desire to conceive (e.g., active attempt to become pregnant or in vitro fertilization) for the duration of the study - Participant agrees to consistently use an effective method of nonhormonal contraception throughout the duration of study, which could include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, non-hormonal intra-uterine devise (IUD), or sterilization. - Able to give informed consent Exclusion Criteria: - • Known renal or liver disease - Known pituitary disorder - Known adrenal disorder - Known thyroid disorder - Use of medication known to alter the cytochrome P450 system - Use of depot-medroxyprogesterone acetate in the previous 6 months or any other hormonal contraceptive in the previous 3 months - Currently breastfeeding - Pregnant - Pregnancy in the prior month - Known allergy to medication - Other specific contraindications to LNG EC |
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Society of Family Planning |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum concentration (Cmax) | Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours | ||
Secondary | Time to maximum concentration (Tmax) | 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours | ||
Secondary | Minimum concentration (Cmin) | Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours | ||
Secondary | Area under the concentration time-curve (AUC) | Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |