Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00160342

Collaborator

(none)

1,251

Enrollment

125

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

Condition or Disease	Intervention/Treatment	Phase
Hot Flushes, Menopause, Postmenopause	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1251 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Experimental: 2	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Experimental: 3	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
Active Comparator: 4	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.30 EE
Experimental: 5	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
Experimental: 6	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
Active Comparator: 7	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.45 EE
Active Comparator: 8	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, 0.60 MT
Placebo Comparator: 9	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT) oral tablet, QD, 12 weeks, Placebo

Outcome Measures

Primary Outcome Measures

Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 [4 weeks]
Mean change in frequency of moderate to severe VMS from baseline to Week 12 [12 weeks]
Mean change in severity of moderate to severe VMS from baseline to Week 4 [4 weeks]
Mean change in severity of moderate to severe VMS from baseline to Week 12 [12 weeks]

Secondary Outcome Measures

Frequency and severity of moderate to severe and all hot flushes at each week [12 weeks]
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome [12 weeks]
Mean change from baseline to Week 12 in vaginal pH [12 weeks]
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
Be a female of any race between the ages of 45-65 years, in generally good health,
Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion Criteria:

Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Contacts and Locations

Locations

	Site	City	State	Country
1	Site 37	Montgomery	Alabama	United States
2	Site 69	Montgomery	Alabama	United States
3	Site 44	Tucson	Arizona	United States
4	Site 6	Jonesboro	Arkansas	United States
5	Site 62	Little Rock	Arkansas	United States
6	Site 70	Carmichael	California	United States
7	Site 85	Carmichael	California	United States
8	Site 87	Northridge	California	United States
9	Site 18	San Diego	California	United States
10	Site 27	San Diego	California	United States
11	Site 54	San Diego	California	United States
12	Site 31	Vista	California	United States
13	Site 68	Walnut Creek	California	United States
14	Site 66	Denver	Colorado	United States
15	Site 4	Groton	Connecticut	United States
16	Site 35	New Britain	Connecticut	United States
17	Site 14	Waterbury	Connecticut	United States
18	Site 25	Aventura	Florida	United States
19	Site 26	Aventura	Florida	United States
20	Site 51	Clearwater	Florida	United States
21	Site 71	Clearwater	Florida	United States
22	Site 61	Daytona Beach	Florida	United States
23	Site 75	Gainesville	Florida	United States
24	Site 33	Pensacola	Florida	United States
25	Site 21	Stuart	Florida	United States
26	Site 82	Tampa	Florida	United States
27	Site 9	Venice	Florida	United States
28	Site 83	West Palm Beach	Florida	United States
29	Site 40	Alpharetta	Georgia	United States
30	Site 90	Alpharetta	Georgia	United States
31	Site 23	Atlanta	Georgia	United States
32	Site 8	Atlanta	Georgia	United States
33	Site 60	Powder Springs	Georgia	United States
34	Site 55	Savannah	Georgia	United States
35	Site 76	Boise	Idaho	United States
36	Site 64	Champaign	Illinois	United States
37	Site 58	Chicago	Illinois	United States
38	Site 72	Chicago	Illinois	United States
39	Site 74	Chicago	Illinois	United States
40	Site 50	Evansville	Indiana	United States
41	Site 52	Baton Rouge	Louisiana	United States
42	Site 65	Mandeville	Louisiana	United States
43	Site 73	Metarie	Louisiana	United States
44	Site 15	Lutherville	Maryland	United States
45	Site 43	Ann Arbor	Michigan	United States
46	Site 12	Chaska	Minnesota	United States
47	Site 80	Chesterfield	Missouri	United States
48	Site 16	Kansas City	Missouri	United States
49	Site 19	Kansas City	Missouri	United States
50	Site 3	St. Louis	Missouri	United States
51	Site 17	Billings	Montana	United States
52	Site 36	Lincoln	Nebraska	United States
53	Site 7	Las Vegas	Nevada	United States
54	Site 28	Reno	Nevada	United States
55	Site 39	New Bern	North Carolina	United States
56	Site 79	Raleigh	North Carolina	United States
57	Site 46	Winston Salem	North Carolina	United States
58	Site 59	Winston Salem	North Carolina	United States
59	Site 45	Cincinnati	Ohio	United States
60	Site 81	Cincinnati	Ohio	United States
61	Site 53	Columbus	Ohio	United States
62	Site 34	Mayfield Heights	Ohio	United States
63	Site 78	Mogadore	Ohio	United States
64	Site 77	Tulsa	Oklahoma	United States
65	Site 13	Portland	Oregon	United States
66	Site 89	Portland	Oregon	United States
67	Site 84	Philadelphia	Pennsylvania	United States
68	Site 63	Pottstown	Pennsylvania	United States
69	Site 22	Warwick	Rhode Island	United States
70	Site 24	Greenville	South Carolina	United States
71	Site 67	Hilton Head	South Carolina	United States
72	Site 10	Chattanooga	Tennessee	United States
73	Site 88	Memphis	Tennessee	United States
74	Site 56	Nashville	Tennessee	United States
75	Site 86	Bryan	Texas	United States
76	Site 20	Corpus Christi	Texas	United States
77	Site 11	Houston	Texas	United States
78	Site 30	San Antonio	Texas	United States
79	Site 41	San Antonio	Texas	United States
80	Site 49	Salt Lake City	Utah	United States
81	Site 47	Charlottesville	Virginia	United States
82	Site 2	Norfolk	Virginia	United States
83	Site 29	Richmond	Virginia	United States
84	Site 48	Richmond	Virginia	United States
85	Site 42	Virginia Beach	Virginia	United States
86	Site 5	Seattle	Washington	United States
87	Site 38	Spokane	Washington	United States
88	Site 32	Tacoma	Washington	United States
89	Site 120	Abbotsford	British Columbia	Canada
90	Site 100	North Vancouver	British Columbia	Canada
91	Site 135	Victoria	British Columbia	Canada
92	Site 116	West Vancouver	British Columbia	Canada
93	Site 122	Winnipeg	Manitoba	Canada
94	Site 93	Winnipeg	Manitoba	Canada
95	Site 111	St. John's	Newfoundland and Labrador	Canada
96	Site 109	Burlington	Ontario	Canada
97	Site 114	Corunna	Ontario	Canada
98	Site 95	Hamilton	Ontario	Canada
99	Site 115	Kingston	Ontario	Canada
100	Site 107	London	Ontario	Canada
101	Site 106	Newmarket	Ontario	Canada
102	Site 137	Ottawa	Ontario	Canada
103	Site 117	Peterborough	Ontario	Canada
104	Site 113	Sarnia	Ontario	Canada
105	Site 92	Sarnia	Ontario	Canada
106	Site 96	Strathroy	Ontario	Canada
107	Site 112	Montreal	Quebec	Canada
108	Site 103	Rimouski	Quebec	Canada
109	Site 119	Sainte Foy	Quebec	Canada
110	Site 94	Sainte Foy	Quebec	Canada
111	Site 91	Shawinigan	Quebec	Canada
112	Site 105	Sherbrooke	Quebec	Canada
113	Site 136	Sherbrooke	Quebec	Canada
114	Site 124	Moscow		Russian Federation
115	Site 125	Moscow		Russian Federation
116	Site 126	Moscow		Russian Federation
117	Site 128	Moscow		Russian Federation
118	Site 129	Moscow		Russian Federation
119	Site 130	Moscow		Russian Federation
120	Site 132	Moscow		Russian Federation
121	Site 133	Moscow		Russian Federation
122	Site 127	St. Petersburg		Russian Federation
123	Site 131	St. Petersburg		Russian Federation
124	Site 134	St. Petersburg		Russian Federation
125	Site 138	St. Petersburg		Russian Federation