Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.30 EE
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.45 EE
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, 0.60 MT
• Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug): oral tablet, QD, 12 weeks, Placebo

Primary outcomes

• 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 outcomes

• 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]

Sex: Female, ages: 45 Years to 65 Years

Inclusion Criteria:

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

Exclusion Criteria:

1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
2. 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

25 more sites not listed.

• Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals

NIH grants: 2005