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

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Wyeth

Status and phase

Completed
Phase 4

Conditions

Postmenopause

Treatments

Drug: 17b Estradiol
Drug: Trimegestone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195455
0753T-101538

Details and patient eligibility

About

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

Enrollment

133 estimated patients

Sex

Female

Ages

45 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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