Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms

EuroPharma

Status and phase: Completed; Phase 2

Conditions: Menopause

Treatments: Dietary Supplement: Low Dose Black Cohosh; Dietary Supplement: Menopause Relief EP-40; Dietary Supplement: Placebo; Dietary Supplement: High Dose Black Cohosh

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03461380

EP-1002

EP-2018-1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 41+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 4 patient groups, including a placebo group

Menopause Relief EP-40

Experimental group

Description:

Fixed combination of black cohosh EP-40 and Rhodiola rosea EPR-7 206.5 mg orally twice daily; daily dose 413 mg of active ingredients

Treatment:

Dietary Supplement: Menopause Relief EP-40

High Dose Black Cohosh

Active Comparator group

Description:

Black cohosh 500 mg orally twice daily; daily dose 1000 mg of active ingredient

Treatment:

Dietary Supplement: High Dose Black Cohosh

Placebo

Placebo Comparator group

Description:

Placebo capsule 600 mg excipients orally twice daily

Treatment:

Dietary Supplement: Placebo

Low Dose Black Cohosh

Active Comparator group

Description:

Black cohosh 6.5 mg orally twice daily; daily dose 13 mg of active ingredient

Treatment:

Dietary Supplement: Low Dose Black Cohosh