Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

Solvay

Status and phase: Completed; Phase 2

Conditions: Hot Flushes, Menopause, Postmenopause

Treatments: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160342

2005-002887-27

S030.2.112

Details and patient eligibility

About

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

Enrollment: 1,251 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,251 participants in 9 patient groups, including a placebo group

1

Active Comparator group

Treatment:

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)

2

Experimental group

Treatment:

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)

3

Experimental group

Treatment:

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)

4

Active Comparator group

Treatment:

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)

5

Experimental group

Treatment:

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)

6

Experimental group

Treatment:

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)

7

Active Comparator group

Treatment:

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)

8

Active Comparator group

Treatment:

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)

9

Placebo Comparator group

Treatment:

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)