Efficacy and Safety of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating

Menopausal Hot Flushes Clinical Trial

Official title:

Multicentric, Randomized, Double Blind Study for Assessment of Efficacy and Tolerability of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02032862
• Other study ID #: 920157
• Status: Terminated
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: July 20, 2015
• Start date: December 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Bioforce AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot flushes daily and a Hyperhidrosis Scale score ≥ 2

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• Menopausal since = 1 year

• = 5 hot flushes /24 hours

• Hyperhidrosis Scale score = 2

Exclusion Criteria:

• Affections like asthma, COPD, depression, diabetes, epilepsy, hyper- and hypothyreosis, malign tumours

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flushing
• Hot Flashes
• Menopausal Hot Flushes

Intervention

Drug:
• Sage extract, 3400 mg , DER 1:17

Locations

Country	Name	City	State
Switzerland	Dr. M. Morger	Saint Gallen	St. Gall

Sponsors (1)

Lead Sponsor	Collaborator
Bioforce AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Hyperhidrosis Disease Severity Scale		Week 12	No
Secondary	Change from Baseline Menopause Rating Scale / MRS		Week 12	No
Secondary	Change from Baseline Modified Dem Tect		Week 12	No