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To Test a New Drug (LCFA-01) for Safety and PK in Healthy Adults for Bacterial Vaginosis Infection.

NCT07514416 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-07

No results posted yet for this study

Summary

This study is being done to check how safe and comfortable LCFA-01 is when used inside the vagina. LCFA-01 is a natural product that contains oleic acid, and it comes as a soft gel capsule that participants will place in the vagina using their fingers.

The main purpose of the study is to make sure the product is safe and does not cause any problems or discomfort. The study will also measure how much of the product stays in the vagina and whether any of it enters the bloodstream. This helps researchers understand how the body absorbs and handles the product.

Finally, the study will also look at early signs of how the product might affect the natural bacteria in the vagina.

In the future, LCFA-01 may be used to treat bacterial vaginosis (BV).

Conditions

  • Bacterial Vaginosis Treatment

Interventions

DRUG

LCFA-01

LCFA-01 Drug Product is a soft gelatin capsule, containing oleic acid at 2 dosage strengths (200 mg and 400 mg).

DRUG

Placebo

LCFA-01 Placebo is a soft gelatin capsule, of which the composition is similar to that of LCFA-01 Drug Product, but without the active pharmaceutical ingredient.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2026-07-17
Completion
2026-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT07514416 on ClinicalTrials.gov