A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women

NCT02269891 | Completed Phase 2

• 1 other identifier: 14NMHB
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the effectiveness of an herbal combination product called Nu Femme, on menopausal symptoms in peri-menopausal women.

Conditions

Menopausal Symptoms

Keywords

Menopausal symptoms; Peri-menopause; Nu Femme; Labisia pumila; Eurycoma longifolia; Hot flash; Joint pain

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of hot flashes

  Assessed based on hot flash symptoms score

  Baseline to week 12

Secondary Outcomes (9)

• Frequency and severity of joint pain

  Baseline to week 12

• Frequency and severity of hot flashes

  Baseline to week 24

• Frequency and severity of hot flashes

  Week 12 to week 24

• Frequency and severity of joint pain

  Baseline to week 24

• Frequency and severity of joint pain

  Week 12 to week 24

Other Outcomes (5)

• Bone markers

  Baseline to week 12

• Blood safety parameters

  Baseline to week 12

• Pap smear

  Baseline to week 12

Study Arms (2)

Nu Femme

EXPERIMENTAL

Two capsules (500mg total) taken once daily in the morning after breakfast for 24 weeks

Dietary Supplement: Nu Femme

Placebo

PLACEBO COMPARATOR

Two capsules taken once daily in the morning after breakfast for 24 weeks

Other: Placebo

Interventions

Nu Femme DIETARY_SUPPLEMENT

Combination product of Labisia pumila and Eurycoma longifolia extracts

Nu Femme

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female of any race between the ages of 40 and 55 years (inclusive)
• Experiencing perimenopause (irregular menstrual cycles (\>3 months) or cessation of menstrual period for at least 3 months within the last 12 months) OR women in menopause (cessation of menstrual period for at least 12 months).
• Peri-menopausal women must have an endometrial stripe \< 8 mm by ultrasound at screening and menopausal women must have an endometrial stripe \< 5 mm. Not required for subjects without an intact uterus.
• Women with an intact cervix must have a pap smear that is normal within 12 months of screening.
• Experiences menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
• Minimum of 4 hot flashes per day or 28 per week
• Total scores of Menopause Rating Scale ≥17 indicating the menopausal symptoms are moderate or severe
• TSH screening to exclude undiagnosed hyperthyroidism
• Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.

You may not qualify if:

• Women with a positive mammogram
• Significant cardiac history including uncontrolled hypertension (defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg) or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
• Uncontrolled hyperlipidemia
• History or current diagnosis of breast cancer or breast cancer in an identical twin, or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to randomization. Subjects with other cancers in full remission more than 5 years after diagnosis are acceptable with the exceptions of breast cancer or genital organ cancer (e.g., cervical cancer, uterine cancer, endometrial cancer, or ovarian cancer)
• Uncontrolled diabetes (Type I or Type II)
• Uncontrolled and/or untreated thyroid disorder
• History or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
• History or current diagnosis of autoimmune conditions, immunodeficiency or gynaecological disease
• Clinically significant mental depression that is not well-controlled in the opinion of the investigator
• Subject has undergone major surgery within the past one year prior to the randomization visit, except cholecystectomy, and appendectomy
• Subject smokes more than 15 cigarettes a day
• History of alcohol or drug abuse within the past year
• Subject has demonstrated non-compliance with treatment while enrolled in other experimental protocols to which the Investigator has knowledge
• Subject has a mental disability or significant mental illness, legal incapacity or limited legal capacity or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or to complete the study
• History or findings of undiagnosed abnormal vaginal bleeding within the previous two years prior to the randomization visit, including conditions that, in the Investigator's opinion are likely to be the source of unpredictable vaginal bleeding (i.e. leiomyoma or endometrial polyps)

Sponsors & Collaborators

• KGK Science Inc.: lead
• Biotropics Malaysia Berhad: collaborator

Study Sites (4)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Manna Research - Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

Manna Research - Quebec

Lévis, Quebec, G6W 0M5, Canada

Location

Manna Research - Montreal

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

MeSH Terms

Conditions

Hot Flashes; Arthralgia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

CA (4)