Prevention of Ovulation Achieved by Single Intra-vaginal Administration of Levogel as Compared to Oral LNG
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ClinicalTrials.gov Identifier: NCT01286948 |
Recruitment Status
:
Completed
First Posted
: January 31, 2011
Last Update Posted
: August 15, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Female Contraception | Drug: Levonorgestrel (LNG) gel (Levogel) and oral LNG (Plan B) | Phase 1 |
A dose of 0.75mg of LNG in a vaginal gel was shown to prevent ovulation in a higher percentage than what has been observed with oral LNG at the approved doses for EC of 1.5mg. Results from a study with a1.5 mg LNG oral dose or a single 0 ,75mg dose demonstrated that the proportion of cycles without follicle rupture or ovulatory dysfunction within 5 days was 86% and 79% respectively (Croxatto et al, 2004) , whereas lack of follicular rupture or the presencr of ovulatory dsyfunction was 96% with administration of a LNG gel formulation. In the group of women with follicle size ≥18mm the gel induced 50% ovulation suppression while oral LNG in previous studies blocked only 16% of ovulation in the same follicle size group . These encouraging results could be explained by higher bioavailability of LNG when administered vaginally. This comparison was made using historical data from another study; therefore this study will compare vaginal administration of LNG to oral in a direct cross-over comparative study.
LNG is known to affect the cervical mucus by making it hostile to sperm penetration and its effect may appear after only a few hours following oral administration (Kesseru, 1984; Brache, unpublished observations). Application of LNG gel in the vagina close to the cervical os may exert a direct effect on the cervical mucus. The potential local action of LNG on the cervical mucus may be another important mechanism by which protection is conferred to women who do not experience ovulation suppression.
An "on demand" precoital contraceptive is an attractive alternative to the post-coital emergency contraception currently available, especially due to the higher efficacy of this route of administration on ovulation suppression as compared with oral tablets of LNG. Should the present study confirm the superiority of vaginal administration of half the dose of the oral dose of LNG approved for emergency contraception, further development of that formulation and method would be warranted.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Cross-over, Clinical Trial to Assess the Prevention of Ovulation Achieved by Single Intra-vaginal Administration of 0.75 mg Levonorgestrel (LNG) Gel (Levogel) as Compared to 1.5 mg Oral LNG |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Levonorgestrel (LNG) gel (Levogel)
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)
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. |
Active Comparator: oral LNG (1.5mg)
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)
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. |
- Comparison of LNG gel and oral LNG on follicle rupture [ Time Frame: 1 year ]The main objective of the study is to compare the effect of LNG gel and oral LNG on follicle rupture as assessed by ultrasound.
- Evaluate effect of single intra-vaginal administration [ Time Frame: 1 year ]
The secondary objectives are to evaluate the effect of single intra-vaginal administration of LNG gel or oral LNG on the:
- growth of the leading follicle
- suppression of the preovulatory peak of serum luteinizing hormone (LH)
- characteristics of the cervical mucus
- serum levels of estradiol (E2) and progesterone (P)

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Ages Eligible for Study: | 21 Years to 39 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy women aged 21-39 years with regular menstrual cycles (25-35 days) and not at risk of pregnancy.
Exclusion Criteria:
- All contraindications to the use of progestins

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286948
Chile | |
Instituto Chileno de Medicina Reproductiva | |
José Victorino Lastarria 29, Santiago, Chile | |
Dominican Republic | |
Profamilia | |
Socorro Sanchez No. 160, Santo Domingo, Dominican Republic, Apartado Postal 1053 |
Principal Investigator: | Vivian Brache, Lic. | Profamilia | |
Principal Investigator: | Regine Sitruk-Ware, PhD. | Population Council | |
Principal Investigator: | María José Miranda Gaete, MD | Instituto Chileno de Medicina Reproductiva |
Responsible Party: | Population Council |
ClinicalTrials.gov Identifier: | NCT01286948 History of Changes |
Other Study ID Numbers: |
Protocol # 441 |
First Posted: | January 31, 2011 Key Record Dates |
Last Update Posted: | August 15, 2017 |
Last Verified: | August 2017 |
Keywords provided by Population Council:
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) |
Additional relevant MeSH terms:
Levonorgestrel Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral |