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

Primary Purpose

Menopausal Hot Flushes

Status

Terminated

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Sage extract, 3400 mg , DER 1:17

About this trial

This is an interventional treatment trial for Menopausal Hot Flushes focused on measuring menopause, hot flushes, hot flashes, salvia, sage, sweating

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Dr. M. Morger

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sage tablets

Placebo

Arm Description

Sage extract, 3400 mg , DER 1:17, in once daily application over 12 weeks treatment phase

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

Outcomes

Primary Outcome Measures

Change from Baseline Hyperhidrosis Disease Severity Scale

Secondary Outcome Measures

Change from Baseline Menopause Rating Scale / MRS

Change from Baseline Modified Dem Tect

Full Information

NCT ID

NCT02032862

First Posted

January 8, 2014

Last Updated

July 20, 2015

Sponsor

A. Vogel AG

1. Study Identification

Unique Protocol Identification Number

NCT02032862

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Terminated

Why Stopped

Insufficient recruitment rate

Study Start Date

December 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

A. Vogel AG

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopausal Hot Flushes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sage tablets

Arm Type

Experimental

Arm Description

Sage extract, 3400 mg , DER 1:17, in once daily application over 12 weeks treatment phase

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sage extract, 3400 mg , DER 1:17

Primary Outcome Measure Information:

Title

Change from Baseline Hyperhidrosis Disease Severity Scale

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Change from Baseline Menopause Rating Scale / MRS

Time Frame

Week 12

Title

Change from Baseline Modified Dem Tect

Time Frame

Week 12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Dr. M. Morger

City

Saint Gallen

State/Province

St. Gall

ZIP/Postal Code

9000

Country

Switzerland

12. IPD Sharing Statement

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

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