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Prevention of Ovulation Achieved by Single Intra-vaginal Administration of Levogel as Compared to Oral LNG

NCT01286948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-15

No results posted yet for this study

Summary

It has been proposed that levonorgestrel (LNG) in a vaginal gel could be used as an 'on demand' contraceptive when used before coitus. Levonorgestrel was selected as it is a component of many approved oral contraceptive pills and also it is the active agent in Plan B, an FDA-approved regimen for emergency contraception (EC). In previous studies it was demonstrated that an LNG vaginal gel was absorbed and was effective in preventing follicular rupture. The overall proportion of cycles with lack of follicular rupture within 5 days of LNG administration or with ovulatory dysfunction (follicle rupture preceded by an inadequate LH surge) was 96% for LNG gel and 39% in the inert gel cycles (control group).

Conditions

  • Female Contraception

Interventions

DRUG

Levonorgestrel (LNG) gel (Levogel) and oral LNG (Plan B)

This is a randomized study with a cross-over design comparing two single dose treatment sequences of either Levogel (LNG vaginal gel 0.750 mg/4g) or oral LNG (1.5mg). All women with a leading follicle diameter of ≥18 mm will be randomized to treatment with a single intra-vaginal application of LNG gel or oral LNG. After a washout cycle, the women will be crossed over to receive the other treatment and the study procedures will be repeated.

Sponsors & Collaborators

  • Population Council

    lead OTHER

Principal Investigators

  • Vivian Brache, Lic. · Profamilia

  • Regine Sitruk-Ware, PhD. · Population Council

  • María José Miranda Gaete, MD · Instituto Chileno de Medicina Reproductiva

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Chile
  • Dominican Republic

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286948 on ClinicalTrials.gov