Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195520

Enrollment

100

Registered

2005-09-19

Start date

2004-12-31

Completion date

2006-12-31

Last updated

2008-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes, Sleep Disorders

Keywords

Menopause, Sleep Disorder, Hot Flashes

Brief summary

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.

Interventions

DRUGTotelle®

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.	—

Secondary

Measure	Time frame
To evaluate the effects of Totelle 1 mg on sexual function and quality of life.	—

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026