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

NCT01286948 | Completed Phase 1 DMC

• 1 other identifier: Protocol # 441
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

LNG gel; oral LNG; follicle rupture; intra-vaginal administration; growth of the leading follicle; preovulatory peak of serum luteinizing hormone; characteristics of the cervical mucus; serum levels of estradiol (E2) and progesterone (P)

Outcome Measures

Primary Outcomes (1)

• Comparison of LNG gel and oral LNG on follicle rupture

  The main objective of the study is to compare the effect of LNG gel and oral LNG on follicle rupture as assessed by ultrasound.

  1 year

Secondary Outcomes (1)

• Evaluate effect of single intra-vaginal administration

  1 year

Study Arms (2)

Levonorgestrel (LNG) gel (Levogel)

ACTIVE COMPARATOR

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.

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

oral LNG (1.5mg)

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Levonorgestrel (LNG) gel (Levogel); oral LNG (1.5mg)

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 21-39 years with regular menstrual cycles (25-35 days) and not at risk of pregnancy.

You may not qualify if:

• All contraindications to the use of progestins

Sponsors & Collaborators

• Population Council: lead

Study Sites (2)

Instituto Chileno de Medicina Reproductiva

José Victorino Lastarria 29, Santiago Metropolitan, Chile

Location

Profamilia

Socorro Sanchez No. 160, Santo Domingo Province, Apartado Postal 1053, Dominican Republic

Location

MeSH Terms

Interventions

Levonorgestrel; Gels

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Vivian Brache, Lic.

  Profamilia

  PRINCIPAL INVESTIGATOR

• Regine Sitruk-Ware, PhD.

  Population Council

  PRINCIPAL INVESTIGATOR

• María José Miranda Gaete, MD

  Instituto Chileno de Medicina Reproductiva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

CL (1); DO (1)