A Phase II Randomised Double-Blind, placebo-controlled clinical trial evaluating the efficacy of Happy Hormones in menopausal women.

Not Applicable

Completed

• Conditions: Menopause; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12621000499886
• Lead Sponsor: Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-29
• Study Completion: 2022-09-30
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

Females between 40 to 66 years of age
More than 3 vasomotor symptoms (hot flushes) within a 24-hour period.
BMI between 18-35 kg/m2
Normal liver and kidney function (within range of the pathology lab used)
Ability to speak and understand English sufficiently to comprehend the purpose and risks of the study and to provide consent

Exclusion Criteria

Undiagnosed vaginal bleeding.
Use of HRT in the previous three months before baseline
Use of any herbal formula that affects hormonal levels in the previous three months before baseline
History of alcohol or drug abuse and currently still drinks more than 2 standard glasses of alcohol daily or uses recreational drugs
History of or current breast, endometrial or ovarian cancer.
Ovariectomy or complete hysterectomy
Uncontrolled and or untreated hypertension (defined as systolic blood pressure >160mm Hg and/ or diastolic blood pressure >100 mm Hg.)
Uncontrolled psychiatric disorders.
Uncontrolled and/or diagnosed medical conditions that may interfere with study medication e.g. Diabetes mellitus, hepatic or renal dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified