Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00137371

Collaborator

(none)

480

Enrollment

Locations

Duration (Months)

9.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrophic Vaginitis Atrophy Vaginitis	Drug: PVC (daily for 21 days, 7 days off) Drug: PVC (twice weekly)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2005

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Female

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Tucson	Arizona	United States	85715
2	Encinitas	California	United States	92024
3	San Diego	California	United States	92108
4	Torrance	California	United States	90502
5	Aurora	Colorado	United States	80010
6	Brooksville	Florida	United States	34613
7	Miami	Florida	United States	33186
8	St. Petersburg	Florida	United States	33709
9	Tampa	Florida	United States	33066
10	West Palm Beach	Florida	United States	33407
11	Atlanta	Georgia	United States	30328
12	Augusta	Georgia	United States	30901
13	Chicago	Illinois	United States	60612
14	Metairie	Louisiana	United States	70006
15	Troy	Michigan	United States	48084
16	St. Louis	Missouri	United States	63141
17	Omaha	Nebraska	United States	68134
18	New Brunswick	New Jersey	United States	08901
19	Chapel Hill	North Carolina	United States	27514
20	Winston-Salem	North Carolina	United States	27103
21	Oklahoma City	Oklahoma	United States	73112
22	Danville	Pennsylvania	United States	17822-2920
23	Philadelphia	Pennsylvania	United States	19104
24	Pittsburgh	Pennsylvania	United States	15206
25	Carrollton	Texas	United States	75006
26	Carrollton	Texas	United States	75010
27	Colleyville	Texas	United States	76034
28	Dallas	Texas	United States	75246
29	Houston	Texas	United States	77030
30	Plano	Texas	United States	75093
31	Charlottesville	Virginia	United States	22903
32	Norfolk	Virginia	United States	23502
33	Calgary	Alberta	Canada	T2N 4L7
34	Coquitlam	British Columbia	Canada	V3K 3V9
35	Langley	British Columbia	Canada	V3H 4H9
36	Winnipeg	Manitoba	Canada	R3A 1M3
37	Winnipeg	Manitoba	Canada	R3A 1R9
38	Kingston	Ontario	Canada	K7L 2V7
39	Ottawa	Ontario	Canada	K1H 7W9
40	Toronto	Ontario	Canada	M5C 1R6
41	Toronto	Ontario	Canada	M5G 1Z5
42	Toronto	Ontario	Canada	M9W 4L6
43	Montreal	Quebec	Canada	H3M 3A9
44	MontrÃ©al	Quebec	Canada	H1T 1P6
45	MontrÃ©al	Quebec	Canada	H2X 1N8
46	Pointe Claire	Quebec	Canada	H9R 4S3
47	QuÃ©bec	Quebec	Canada	G1L 3L5
48	Shawinigan	Quebec	Canada	G9N 2H6
49	Sherbrooke	Quebec	Canada	J1H 5N4