Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00137371

Enrollment

480

Registered

2005-08-29

Start date

2005-08-31

Completion date

2007-09-30

Last updated

2007-12-10

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

Conditions

Atrophic Vaginitis, Atrophy, Vaginitis

Keywords

Postmenopause, Vaginitis

Brief summary

This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.

Interventions

DRUGPVC (daily for 21 days, 7 days off)

DRUGPVC (twice weekly)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 80 Years

Inclusion criteria

Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse. The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.

Exclusion criteria

Women who do not have a clinical diagnosis of atrophic vaginitis.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.	—

Secondary

Measure	Time frame
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.	—

Countries

Canada, United States

Outcome results

None listed

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