NCT00472004: Two menopausal hormone regimens in Mexico

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

This randomized, open-label phase IV study compared two menopausal hormone regimens in Mexico. The Wyeth/Pfizer record lists 204 actual participants, postmenopausal women aged approximately 45–55 with vasomotor symptoms, and a completed status in its October 2010 update. 1 2

One regimen combined 17-beta-estradiol 1 mg with trimegestone 0.125 mg continuously; the other was tibolone. Here, the abbreviation TMG refers to trimegestone. The study concerned symptom control and treatment tolerability in that defined population. 1 2

Verified comparative symptom changes or adverse-event rates were not recovered from the inspected record. A randomized protocol is not itself evidence that one option is better, and it does not establish that hormone treatment is appropriate for someone with different risks or medical history. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00472004. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00472004. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.