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Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.

NCT03897738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2020-02-20

No results posted yet for this study

Summary

To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart B in women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms in perimenopause.

Conditions

  • Perimenopause, Climacteric Syndrome

Interventions

DIETARY_SUPPLEMENT

Amberen

Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.

DIETARY_SUPPLEMENT

Smart B

Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.

DIETARY_SUPPLEMENT

Placebo

Placebo capsules are identical to Amberen and Smart B capsules.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-02-18
Completion
2020-02-18

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897738 on ClinicalTrials.gov