Menopausal Hot FlushesPhase 4NCT02032862
Efficacy and Safety of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating
A Phase 4 study testing Sage extract, 3400 mg , DER 1:17 in people with Menopausal Hot Flushes, run by A. Vogel AG at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Menopausal Hot Flushes
- What is being tested?
- Sage extract, 3400 mg , DER 1:17
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal since ≥ 1 year
- ≥ 5 hot flushes /24 hours
- Hyperhidrosis Scale score ≥ 2
Who cannot join
- Affections like asthma, COPD, depression, diabetes, epilepsy, hyper- and hypothyreosis, malign tumours
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Menopausal Hot Flushes
- Being tested
- Sage extract, 3400 mg , DER 1:17
- Keywords
- menopause, hot flushes, hot flashes, salvia, sage, sweating
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage extract, 3400 mg , DER 1:17Drug
| Study group | Role | What they receive |
|---|---|---|
| Sage tablets | Experimental | Sage extract, 3400 mg , DER 1:17, in once daily application over 12 weeks treatment phase Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Hyperhidrosis Disease Severity Scale
Measured: Week 12
Secondary outcomes (2)
Change from Baseline Menopause Rating Scale / MRS
Measured: Week 12
Change from Baseline Modified Dem Tect
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Insufficient recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal Hot FlushesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032862
- Sponsor's protocol ID
- 920157
- Status last verified
- Jul 2015
- First submitted
- 8 Jan 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02032862
- Acronym / sponsor ID
- 920157
- Conditions
- Menopausal Hot Flushes
- Keywords
- menopause, hot flushes, hot flashes, salvia, sage, sweating
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment rate
- Enrolment
- 107 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sage tablets | Experimental | Drug: Sage extract, 3400 mg , DER 1:17Sage extract, 3400 mg , DER 1:17, in once daily application over 12 weeks treatment phase |
| Placebo | Placebo comparator | –Placebo, matching the verum in size and appearance, in once daily application over 12 weeks treatment phase |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Menopausal since ≥ 1 year
- ≥ 5 hot flushes /24 hours
- Hyperhidrosis Scale score ≥ 2
Key exclusion criteria (1 listed)
- Affections like asthma, COPD, depression, diabetes, epilepsy, hyper- and hypothyreosis, malign tumours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sage extract, 3400 mg , DER 1:17 | Drug | Sage tablets |
Primary outcome
Change from Baseline Hyperhidrosis Disease Severity Scale
Time frame: Week 12
2 secondary outcomes
Change from Baseline Menopause Rating Scale / MRS
Time frame: Week 12
Change from Baseline Modified Dem Tect
Time frame: Week 12
Results and safety
The study was stopped early (reason given: Insufficient recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sage extract, 3400 mg , DER 1:17 in people with Menopausal Hot Flushes, run by A. Vogel AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Hyperhidrosis Disease Severity Scale (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.