Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

Wyeth

Status and phase: Completed; Phase 4

Conditions: Sleep Disorders; Hot Flashes

Treatments: Drug: Totelle®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195520

0753T-101537

Details and patient eligibility

About

To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.

Enrollment: 100 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intact uterus
• Generally health postmenopausal women 45 to 60 years of age, inclusive
• Sexually active
• No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.

Exclusion criteria

• Known or suspect estrogen-dependent neoplasia
• Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
• Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)