Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160342

Purpose

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	Intervention	Phase
Hot Flushes, Menopause, Postmenopause	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean change in frequency of moderate to severe VMS from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean change in severity of moderate to severe VMS from baseline to Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean change in severity of moderate to severe VMS from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency and severity of moderate to severe and all hot flushes at each week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to Week 12 in vaginal pH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1251
Study Start Date:	June 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160342

Show 125 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Sheri Rhodes )
Study ID Numbers:	S030.2.112, 2005-002887-27
Study First Received:	September 9, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00160342 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Hormone replacement therapy, hot flushes, postmenopause

Additional relevant MeSH terms:

Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hot Flashes
Methyltestosterone
Hormones
Pharmacologic Actions

Testosterone 17 beta-cypionate
Estrogens, Esterified (USP)
Signs and Symptoms
Anabolic Agents
Testosterone
Therapeutic Uses
Flushing
Androgens
Estrone

ClinicalTrials.gov processed this record on February 08, 2010