Alternative Treatments for Menopausal Women
1 other identifier
interventional
61
1 country
1
Brief Summary
To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
January 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 6, 2015
February 1, 2015
2.5 years
July 12, 2012
February 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Menopause-related symptoms
To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.
3 months
Study Arms (2)
Red Clover extract
ACTIVE COMPARATOR150 ml/d Red Clover extract
Placebo
PLACEBO COMPARATOR150 ml/d sweetened and coloured water
Interventions
Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
Eligibility Criteria
You may qualify if:
- Women aged 40-65 years
- Experiencing daily hot flushes
- Body Mass Index (BMI) between 20-40
- Irregular menstrual bleeding
- FSH levels above the normal range
You may not qualify if:
- Simultaneous participation in other clinical trials within the last 3 months
- Severe cardiovascular, psychiatric, neurological, and/or kidney disease.
- Alcohol or drug abuse and acute illness.
- Blood pressure \> 160/110
- Pregnant and lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Clinical Research, Hospital Vendsyssel
Hjørring, North Denmark, 9800, Denmark
Related Publications (1)
Lambert MNT, Thorup AC, Hansen ESS, Jeppesen PB. Combined Red Clover isoflavones and probiotics potently reduce menopausal vasomotor symptoms. PLoS One. 2017 Jun 7;12(6):e0176590. doi: 10.1371/journal.pone.0176590. eCollection 2017.
PMID: 28591133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per B Jeppesen, Prof
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Prof., PhD
Study Record Dates
First Submitted
July 12, 2012
First Posted
January 7, 2014
Study Start
June 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 6, 2015
Record last verified: 2015-02