NCT02032862

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

January 8, 2014

Last Update Submit

July 20, 2015

Conditions

Menopausal Hot Flushes

Keywords

menopause, hot flushes, hot flashes, salvia, sage, sweating

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Hyperhidrosis Disease Severity Scale

    Week 12

Secondary Outcomes (2)

  • Change from Baseline Menopause Rating Scale / MRS

    Week 12

  • Change from Baseline Modified Dem Tect

    Week 12

Study Arms (2)

Sage tablets

EXPERIMENTAL

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

PLACEBO COMPARATOR

Placebo, matching the verum in size and appearance, in once daily application over 12 weeks treatment phase

Interventions

Sage extract, 3400 mg , DER 1:17DRUG
Sage tablets

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Menopausal since ≥ 1 year
  • ≥ 5 hot flushes /24 hours
  • Hyperhidrosis Scale score ≥ 2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. M. Morger

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 10, 2014

Study Start

December 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

CH(1)