A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women (14NMHB)

KGK Science

Status and phase

Completed

Phase 2

Conditions

Menopausal Symptoms

Treatments

Other: Placebo

Dietary Supplement: Nu Femme

Study type

Interventional

Funder types

Industry

Identifiers

NCT02269891

14NMHB

Details and patient eligibility

About

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.

Enrollment

119 patients

Sex

Female

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

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