Clinical trial NCT02863445: Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
Official title: Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - Pharmacodynamics of 3.0mg LNG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Obesity
Body weight
Emergency contraception
Levonogestrel
Ulipristal acetate
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-08-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: The Number of Participants in Two Treatment Groups (1.5mg Levonorgestrel and 3mg Levonorgestrel) With no Follicle Rupture at 5 Days Within One Menstrual (Treatment) Cycle.
timeFrame: 5 days post-LNG dosing
Secondary outcomes:
measure: Number of Participants With Follicle Rupture Before 5 Days
timeFrame: 5 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edelman AB, Cherala G, Blue SW, Erikson DW, Jensen JT. Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception. 2016 Jul;94(1):52-7. doi: 10.1016/j.contraception.2016.03.006. Epub 2016 Mar 18.
citation: Edelman AB, Hennebold JD, Bond K, Lim JY, Cherala G, Archer DF, Jensen JT. Double Dosing Levonorgestrel-Based Emergency Contraception for Individuals With Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jul 1;140(1):48-54. doi: 10.1097/AOG.0000000000004717. Epub 2022 Jun 7.