Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort

Lumara Health

Status and phase: Completed; Phase 2

Conditions: Vulvodynia

Treatments: Drug: lidocaine; Drug: placebo; Drug: Lidocaine/Diphenhydramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00590590

LDC-201-601-669020

Details and patient eligibility

About

This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have sought doctor's care for this condition.
• Patients must be having menstrual cycles.

Exclusion criteria

• Patients must not have any vaginal infections.
• Patients must not be pregnant or nursing.
• Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

3 (Placebo)

Placebo Comparator group

Treatment:

Drug: placebo

1 (Lidocaine)

Experimental group

Treatment:

Drug: lidocaine

2 (Lidocaine/Diphenhydramine)

Experimental group

Treatment:

Drug: Lidocaine/Diphenhydramine