Clinical trial NCT03461380: Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms
Official title: Efficacy of Menopause Relief EP-40 - Fixed Combination of Cimicifuga EP-40 and Rhodiola EPR-7 Extracts in Women With Menopausal Symptoms: A Randomized, Double Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menopause
Keywords: Cimicifuga, Rhodiola, Menopause Symptoms
Lead sponsor: EuroPharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: I.Zhordania Institute of Reproductology
First posted: 2018-03-12
Enrollment: 220
Sex: FEMALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the efficacy of a fixed combination of black cohosh (EP-40) and Rhodiola rosea (EPR-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh extract only in adult woman with menopausal complaints.

Detailed description: Due to the problems caused by Hormone Replacement Therapy with chemical entities, some medicinal plants used in the traditional systems of medicine have shown immense potential in non-hormonal treatment of menopausal symptoms without major adverse events. We hypothesize that Menopause Relief EP-40 (a fixed combination of Cimicifuga EP-40 and Rhodiola EPR-7 extracts) will significantly relieve menopausal complaints such as hot flushes, profuse sweating hot flushes, excessive perspiration, night sweats, sleep disorders, nervousness, mood swings, physical and mental fatigue as compared to EP-40® capsules or placebo in adult females in menopause.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of menopausal female climacteric states (N95.1 according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision, ICD-10, Version for 2014) which is characterized by symptoms such as flushing, sleeplessness, headache, lack of concentration associated with menopause, etc
* Patients suffering from menopausal syndrome with neurovegetative components which have been stable anamnestically during the last 2 weeks
* No medication taken for management of menopausal syndrome with neurovegetative components during the last 4 weeks
* Ability to understand and provide signed informed consent
* Ability to participate in the study
* In some cases, diagnosis should be confirmed by blood tests of follicle-stimulating hormone (≥ 40 IU/L) \[postmenopausal status\], thyroid function with normal serum free T4 (fT4), estrogen (estrodiol levels) \[premenopausal 30-400 pg/mL; after menopause \<30 pg/mL\]

Exclusion Criteria:

* subjects with previous or current psychological disease that could interfere with their ability to participate in the study
* anamnestic or current alcohol or drug abuse
* concomitant treatment with psychotropic (in particular benzodiazepines, antidepressants, hypnotics or neuroleptics, tamoxifen, clomiphene, and danazol) or hormonally acting drugs such as hormone replacement therapy (HRT)
* hyperthyroidism
* malignant tumors
* continuous climacteric bleeding and complaints related to myomas
* patients who have taken another experimental drug within a 4-week period prior to the trial
* pregnancy/lactation
* serious internal disease
* previous organ transplantation
* premenopausal women with insufficient contraceptive protection
* hypersensitivity to one of the ingredients of the trial medication
* a body mass index of \>30

Primary outcomes:
measure: Kupperman Menopausal Index (KMI)
timeFrame: 12 weeks
measure: Menopause Rating Scale (MRS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: I.Zhordania Institute of Reproductology
Study officials:
affiliation: I.Zhordania Institute of Reproductology, Tevdore Mgvdeli Street, Tbilisi, Georgia
name: Lali Phkhaladze, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: