Phase 4
Completed N=70
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
Source: ClinicalTrials.gov NCT02863445 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: 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. — 18; 24 participants
◆ Published Evidence
Emerging
19citations · ~5 / year
Double Dosing Levonorgestrel-Based Emergency Contraception for Individuals With Obesity: A Randomized Controlled Trial.
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.
Linked Publications
-
Double Dosing Levonorgestrel-Based Emergency Contraception for Individuals With Obesity: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
18; 24 | — |
| SECONDARY Number of Participants With Follicle Rupture Before 5 Days |
17; 11 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02863445) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.