Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195455

Enrollment

133

Registered

2005-09-19

Start date

2005-02-28

Completion date

2007-03-31

Last updated

2007-12-20

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

Conditions

Postmenopause

Keywords

Postmenopause

Brief summary

The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

Interventions

DRUGTrimegestone

DRUG17b Estradiol

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day * Intact uterus

Exclusion criteria

* Known or suspected breast carcinoma or estrogen-dependent neoplasm * Undiagnosed abnormal genital bleeding

Design outcomes

Primary

Measure	Time frame
To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.	—

Secondary

Measure	Time frame
Study bleeding patterns throughout the treatment period (6 months)	—
Evaluate changes in the Menopause-Specific Quality of Life Questionnaire	—

Countries

Mexico

Outcome results

None listed

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