Vasomotor symptoms (VMS) and endothelial function: A randomised placebo-controlled trial of oral micronised Progesterone (Prometrium ®)

Completed

• Conditions: Menopause; Urological and Genital Diseases; Menopausal and other perimenopausal disorders

• Registration Number: ISRCTN16052610
• Lead Sponsor: Centre for Menstrual Cycle and Ovulation Research (CeMCOR) (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 165

Inclusion Criteria

Women past menopause who are between one and ten years of their last menstrual period, not on any hormones for at least the past 6 months, experiencing hot flushes or night sweats and without any history or risk factors of heart disease (smoking, overweight, high lipid levels).

Exclusion Criteria

Amendment to protocol as of 17/05/2006:
1. Any menstruation in the preceding year
2. History of hysterectomy without ovariectomy unless she is 60 years of age
3. Use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) in the preceding six months
4. Any risk factors for heart disease like smoker, high blood pressure, high cholesterol, diabetes, overweight, and history of angina or abnormal electrocardiogram (ECG)

Study & Design

• Study Type: Interventional
• Study Design: Not specified