Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00727129

Enrollment

495

Registered

2008-08-01

Start date

2004-07-31

Completion date

2005-08-31

Last updated

2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Symptoms

Keywords

vasomotor symptoms, estrogen, estradiol, hot flashes

Brief summary

The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.

Interventions

DRUGDivigel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Postmenopausal women * Have moderate to severe hot flashes * Normal Pap Smear

Exclusion criteria

* Abnormal mammogram * Abnormal clinical breast exam * BMI \>35

Design outcomes

Primary

Measure	Time frame
Daily frequency and severity of moderate to severe vasomotor symptoms	—

Secondary

Measure	Time frame
vulvar and vaginal atrophy	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026