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

This study has been terminated.
(Insufficient recruitment rate)
Information provided by (Responsible Party):
Bioforce AG Identifier:
First received: January 8, 2014
Last updated: July 20, 2015
Last verified: July 2015
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

Condition Intervention Phase
Menopausal Hot Flushes
Drug: Sage extract, 3400 mg , DER 1:17
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bioforce AG:

Primary Outcome Measures:
  • Change from Baseline Hyperhidrosis Disease Severity Scale [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Change from Baseline Menopause Rating Scale / MRS [ Time Frame: Week 12 ]
  • Change from Baseline Modified Dem Tect [ Time Frame: Week 12 ]

Enrollment: 107
Study Start Date: December 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sage tablets
Sage extract, 3400 mg , DER 1:17, in once daily application over 12 weeks treatment phase
Drug: Sage extract, 3400 mg , DER 1:17
Placebo Comparator: Placebo
Placebo, matching the verum in size and appearance, in once daily application over 12 weeks treatment phase


Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02032862

Dr. M. Morger
Saint Gallen, St. Gall, Switzerland, 9000
Sponsors and Collaborators
Bioforce AG
  More Information

Responsible Party: Bioforce AG Identifier: NCT02032862     History of Changes
Other Study ID Numbers: 920157
Study First Received: January 8, 2014
Last Updated: July 20, 2015

Keywords provided by Bioforce AG:
menopause, hot flushes, hot flashes, salvia, sage, sweating

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms processed this record on April 25, 2017