Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00141570

Collaborator

(none)

350

Enrollment

Locations

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets

Condition or Disease	Intervention/Treatment	Phase
Menopause	Drug: esterified estrogens 0.625 mg and methyltestosterone 1.25 mg	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12 []

Secondary Outcome Measures

Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Menopausal women between the ages of 30 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement

Contacts and Locations

Locations

	Site	City	State	Country
1	Site 66	Huntsville	Alabama	United States
2	Site 57	Mobile	Alabama	United States
3	Site 46	Montgomery	Alabama	United States
4	Site 29	Phoenix	Arizona	United States
5	Site 15	Tucson	Arizona	United States
6	Site 3	Jonesboro	Arkansas	United States
7	Site 22	Little Rock	Arkansas	United States
8	Site 68	Carmichael	California	United States
9	Site 55	Encinitas	California	United States
10	Site 6	San Diego	California	United States
11	Site 45	Santa Rosa	California	United States
12	Site 25	Walnut Creek	California	United States
13	Site 26	Denver	Colorado	United States
14	Site 1	Groton	Connecticut	United States
15	Site 54	Hartford	Connecticut	United States
16	Site 30	Trumbull	Connecticut	United States
17	Site 34	Waterbury	Connecticut	United States
18	Site 10	Aventura	Florida	United States
19	Site 73	Ft. Myers	Florida	United States
20	Site 51	Leesburg	Florida	United States
21	Site 49	Melbourne	Florida	United States
22	Site 64	New Port Richey	Florida	United States
23	Site 61	Ocala	Florida	United States
24	Site 27	Palm Springs	Florida	United States
25	Site 11	Pinellas Park	Florida	United States
26	Site 75	Sarasota	Florida	United States
27	Site 69	St. Petersburg	Florida	United States
28	Site 70	Venice	Florida	United States
29	Site 17	West Palm Beach	Florida	United States
30	Site 50	Alpharetta	Georgia	United States
31	Site 5	Atlanta	Georgia	United States
32	Site 44	Decatur	Georgia	United States
33	Site 77	Douglasville	Georgia	United States
34	Site 9	Riverdale	Georgia	United States
35	Site 7	Savannah	Georgia	United States
36	Site 47	Boise	Idaho	United States
37	Site 24	Champaign	Illinois	United States
38	Site 20	Chicago	Illinois	United States
39	Site 76	Peoria	Illinois	United States
40	Site 58	Evansville	Indiana	United States
41	Site 39	Wichita	Kansas	United States
42	Site 59	Baton Rouge	Louisiana	United States
43	Site 52	New Orleans	Louisiana	United States
44	Site 53	Ann Arbor	Michigan	United States
45	Site 63	Kansas City	Missouri	United States
46	Site 32	Richmond Heights	Missouri	United States
47	Site 36	St. Louis	Missouri	United States
48	Site 72	Billings	Montana	United States
49	Site 21	Lincoln	Nebraska	United States
50	Site 37	Reno	Nevada	United States
51	Site 65	Cary	North Carolina	United States
52	Site 13	New Bern	North Carolina	United States
53	Site 16	Winston-Salem	North Carolina	United States
54	Site 60	Columbus	Ohio	United States
55	Site 67	Oklahoma City	Oklahoma	United States
56	Site 40	Tulsa	Oklahoma	United States
57	Site 62	Eugene	Oregon	United States
58	Site 41	Medford	Oregon	United States
59	Site 33	Portland	Oregon	United States
60	Site 18	Erie	Pennsylvania	United States
61	Site 19	Philadelphia	Pennsylvania	United States
62	Site 23	Pottstown	Pennsylvania	United States
63	Site 31	Anderson	South Carolina	United States
64	Site 35	Greer	South Carolina	United States
65	Site 4	Chattanooga	Tennessee	United States
66	Site 74	Conroe	Texas	United States
67	Site 8	Corpus Christi	Texas	United States
68	Site 71	Dallas	Texas	United States
69	Site 42	Houston	Texas	United States
70	Site 14	San Antonio	Texas	United States
71	Site 38	Salt Lake City	Utah	United States
72	Site 28	Norfolk	Virginia	United States
73	Site 12	Richmond	Virginia	United States
74	Site 56	Renton	Washington	United States
75	Site 2	Seattle	Washington	United States
76	Site 48	Spokane	Washington	United States
77	Site 43	Tacoma	Washington	United States