NCT02859337CompletedPhase 4
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
Source: ClinicalTrials.gov · Last updated 6 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 4 Aug 2016
- Start date
- 30 May 2017
- Primary completion date
- 13 Jan 2022
- Lead sponsor
- Oregon Health and Science University
- Diseases
- Obesity
- NCT number
- NCT02859337
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 64
- From 30 May 2017 to the primary completion date, 13 Jan 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of drugs that interfere with metabolism of sex steroids
Other illness
- Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
Other
- 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
- Smokers.
Who the study is looking for
- 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.
Age in the registry: 18 years to 35 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OHSU Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.