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Trial record 12 of 701 for:    eating disorders OR anorexia OR appetite disorder OR binge eating disorder OR bulimia OR coprophagia OR hyperphagia OR pica disease OR purge OR orthorexia OR feeding behaviors OR nutrition disorders OR obesity OR thinness OR women's health | Recruiting, Not yet recruiting, Available Studies | NIH

Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG (EC-Obesity)

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ClinicalTrials.gov Identifier: NCT02863445
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

Brief Summary:
Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG aspect of the study procedures.

Condition or disease Intervention/treatment Phase
Obesity Drug: Levonorgestrel-based emergency contraception 1.5 mg Drug: Levonorgestrel-based emergency contraception 3.0mg Phase 4

Detailed Description:

Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo.

The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. The hypothesis is that increasing the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. In the overall proposal, the investigators plan to perform detailed pharmacokinetic and pharmacodynamic studies of ulipristal acetate-based EC in obese women and expand upon the preliminary findings of levonorgestrel-based EC. This protocol registration is for the LNG aspect of the study procedures focused on the pharmacodynamics of LNG dose escalation


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - Pharmacodynamics of 3.0mg LNG
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Active Comparator: LNG-ECx1
Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Drug: Levonorgestrel-based emergency contraception 1.5 mg
Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
Other Names:
  • Plan B
  • Next Choice

Experimental: LNG-ECx2
Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Drug: Levonorgestrel-based emergency contraception 3.0mg
Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC




Primary Outcome Measures :
  1. The proportion of obese women with no follicle rupture (yes/no) between the two treatment groups (1.5mg levonorgestrel and 3mg levonorgestrel) [ Time Frame: 1 menstrual cycle (up to a 35 day time period) ]
    Follicle rupture by ultrasound. Defined as the disappearance of or >50% reduction in the size of the leading follicle.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally health women
  • Aged 18-35 years old
  • Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3ng/ml or greater.
  • Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.

Exclusion Criteria:

  • Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
  • Impaired liver or renal function
  • Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
  • Recent (within last 8 weeks) use of hormonal contraception
  • Current use of drugs that interfere with metabolism of sex steroids
  • Smokers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863445


Contacts
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Contact: Women's Health Research Unit Department of Ob/Gyn 503-494-3666 whru@ohsu.edu

Locations
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United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Women's Health Research Unit    503-494-3666    whru@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University

Publications:
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Responsible Party: Alison Edelman, Professor, OB/GYN, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02863445     History of Changes
Other Study ID Numbers: OHSU IRB 16291
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

PI acknowledges willingness to share data and materials with other investigators through established means. Data will be shared with collaborators as soon as available; with other scientists before publication if the work to be done is different from the PI's purposes; with local colleagues at seminars and talks including the yearly university-wide research-in-progress seminar; and with the scientific community at large by posters and presentations at local, regional, national, and international scientific meetings. Data will be presented via publication to the widest audience possible.

Transfer of resources is subject to the acceptance of a Materials Transfer Agreement as required by policy at OHSU.

OHSU complies with NIH policy on Sharing Research Data and on Sharing Model Organisms.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alison Edelman, Oregon Health and Science University:
Obesity
Body weight
Emergency contraception
Levonogestrel
Ulipristal acetate
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral