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

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ClinicalTrials.gov Identifier: NCT02859337
Recruitment Status : Recruiting
First Posted : August 9, 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. Our 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. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.

Condition or disease Intervention/treatment Phase
Obesity Contraception Drug: UPA-ECx1 Drug: UPA-ECx2 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.

Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. We hypothesize 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, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of UPA-based EC in obese women and expand upon our preliminary findings of LNG-based EC. This protocol registration is for the UPA aspect of the study procedures focused on the pharmacokinetics and pharmacodynamics of UPA and will include a dose escalation intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
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: UPA-ECx1 followed by ECx2
Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.
Drug: UPA-ECx1
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
Other Names:
  • Ella
  • Ella-One

Drug: UPA-ECx2
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
Other Names:
  • ella
  • ella-one

Experimental: UPA-ECx2 followed by ECx1
Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.
Drug: UPA-ECx1
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
Other Names:
  • Ella
  • Ella-One

Drug: UPA-ECx2
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
Other Names:
  • ella
  • ella-one

UPA-ECx1 Normal BMI/weight
Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
Drug: UPA-ECx1
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
Other Names:
  • Ella
  • Ella-One




Primary Outcome Measures :
  1. Delay in follicular rupture [ Time Frame: 1 menstrual cycle ]
    Follicular rupture (yes/no) by ultrasound between treatment groups (30 vs 60 mg of UPA). Defined as the disappearance of or >50% reduction in size of the leading follicle


Secondary Outcome Measures :
  1. Maximum serum concentration [ Time Frame: 24 hours ]
    Maximum serum concentration (Cmax) of obese users of 30 versus 60 mg of UPA and between obese and normal BMI users of 30mg UPA



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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 healthy women
  • Aged 18-35 years old
  • Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
  • Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI <25kg/m2 and a weight of less than 80kg.

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): NCT02859337


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
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

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Responsible Party: Alison Edelman, Professor, OB/GYN, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02859337     History of Changes
Other Study ID Numbers: OHSU IRB 016291
First Posted: August 9, 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 our purposes; with local colleagues at seminars and talks including our 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alison Edelman, Oregon Health and Science University:
obesity
body weight
BMI
emergency contraception
levonorgestrel
ulipristal acetate
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs