Clinical trial NCT02269891: A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women
Official title: A Randomized Double-Blind, Placebo-Controlled, Parallel Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menopausal Symptoms
Keywords: Menopausal symptoms
Peri-menopause
Nu Femme
Labisia pumila
Eurycoma longifolia
Hot flash
Joint pain
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biotropics Malaysia Berhad
First posted: 2014-10-21
Enrollment: 119
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)
* Subject has uterine fibroids (\> 2cm) or endometriosis. This assessment will be based on the size of the uterus of each participant and will be assessed by the Qualified Investigator
* Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Positive urine pregnancy test result
* Polycystic ovary syndrome (PCOS)
* History of abnormal Pap smear
* Significant abnormal liver function as defined as AST and/or ALT \> 2 x the upper limit of normal (ULN), and/or bilirubin \> 2 x the ULN
* eGFR \<60
* Bleeding disorders or anaemia of any etiology defined as haemoglobin ≤ 110 g/L
* Subject has taken any of the following medications in the time periods specified prior to the screening visit and during the study

Sex hormones:

Vaginal rings and vaginal creams, ointments or gels 1 week Transdermal or topical 4 weeks DHEA within 24 weeks Natural supplements advertised to have hormonal effects within 4 weeks Oral within 4 weeks Intrauterine progestin implants within 8 weeks Progestin implants and estrogen alone injections within 12 weeks Injected progestin and estrogen or androgen implants or pellets within 24 weeks

Gonadotropin-releasing hormone (GnRH) agonists within 24 weeks

Selective Estrogen Receptor Modulators (SERMs) within 4 weeks

Glucocorticoids - Chronic high dose (≥ 7.5 mg prednisone per day or equivalent) for the past 12 weeks. Exceptions: Chronic low dose corticosteroid use (\< 7.5 mg prednisone per day, or equivalent) is permitted provided the subject has been stabilized on a dose for at least 12 weeks prior to randomization and maintains the current dose and dosing regimen during the study. Acute topical, inhaled, or oral (e.g. dose packs) use is not exclusionary and will be permitted during the course of the study.

Antidepressant and/or antianxiety medications within 4 weeks unless a chronic stable dose has been maintained for greater than 12 weeks. Subject must maintain current dose and dosing regimen during the study. Use of Effexor (Venlafaxine HCl) within 4 weeks is exclusionary. Use of Dixarit (Clonidine HCl) within 2 weeks is exclusionary.

Thyroid or anti-epileptic medications within 12 weeks unless a chronic stable dose has been maintained for greater than 12 weeks prior to randomization. Subjects must maintain current dose and dosing regimen during the study

Use of Prostaglandins within 4 weeks

Other investigational study medications within 4 weeks

Current use of propranolol

Current use of an intrauterine device (IUD)

Use of natural health products, such as primrose oil, black cohosh, soy products, other than vitamin and/or mineral supplements within 4 weeks

* Known allergy or hypersensitivity to study product ingredients
* Subjects on a weight reduction program or a medically supervised diet.
* Unexplained weight loss or weight gain of more than 5 kg in the month prior to randomization
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Primary outcomes:
measure: Frequency and severity of hot flashes
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Frequency and severity of joint pain
timeFrame: Baseline to week 12
measure: Frequency and severity of hot flashes
timeFrame: Baseline to week 24
measure: Frequency and severity of hot flashes
timeFrame: Week 12 to week 24
measure: Frequency and severity of joint pain
timeFrame: Baseline to week 24
measure: Frequency and severity of joint pain
timeFrame: Week 12 to week 24
measure: Health related quality of life
timeFrame: Baseline to weeks 3, 6, 12 and 24
measure: Menopause specific quality of life
timeFrame: Baseline to weeks 3, 6, 12 and 24
measure: Serum hormone concentrations
timeFrame: Baseline to week 12
measure: Serum Lipid Profile
timeFrame: Baseline to week 12
Other outcomes:
measure: Bone markers
timeFrame: Baseline to week 12
measure: Blood safety parameters
timeFrame: Baseline to week 12
measure: Pap smear
timeFrame: Baseline to week 12
measure: Pelvic ultrasound
timeFrame: Baseline to week 12
measure: Incidence of adverse events
timeFrame: Baseline to week 12
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
city: Toronto
country: Canada
facility: Manna Research - Toronto
state: Ontario
city: Levis
country: Canada
facility: Manna Research - Quebec
state: Quebec
city: Pointe Claire
country: Canada
facility: Manna Research - Montreal
state: Quebec
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: