Climateric symptoms Urological and Genital Diseases Menopausal and female climacteric states
Conditions
Interventions
Subjects will be randomized to receive either the test drug or placebo for 24 weeks
1. Test drug = 17beta-estradiol (0.5 mg) + norethisterone acetate (0.1 mg)
2. Placebo
Frequency of administration
Sponsors
LIBBS Farmaceutica Ltd (Brazil)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women aged 40 to 65 years 2. Intact uterus 3. Natural menopause, defined as (amenorrhea for at least 12 months and menopausal status must be confirmed by demonstrating levels of follicle stimulating hormone (FSH) > 30 mIU/mL and estradiol < 30 pg/ml) 4. Body mass index (BMI) between 19 and 35.0 kg/m2 5. A minimum average frequency of 50 moderate to severe hot flushes or night sweats episodes per week, as recorded by patient in the screening phase
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to products containing estrogen and/or progestin 2. Surgical menopause 3. Endometrial thickness (bi-laminar) > 5 mm, measured by transvaginal ultrasound 4. Evidence of endometrial polyp by transvaginal ultrasound 5. Abnormal Pap smear, including cervical intraepithelial neoplasia (CIN) or cervical cancer 6. Prior exposure to hormone therapy with estrogen alone or combined therapy with estrogen/progestin, considering the following period before pre-selection (V0): 6.1 Vaginal therapy (cream, gel, vaginal capsule) - 150 mmHg and/or diastolic pressure > 90 mm Hg (patients with hypertension controlled with antihypertensive drugs may be admitted in the study) 17. History of arterial or venous thromboembolic disease, including myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism 18. History of hepatobiliary disease with hepatic enzymes elevation 19. Women smoking more than 20 cigarettes/day 20. History of alcohol or substance abuse 21. Any condition evaluated by medical history, physical examination or screening test (including but not limited to cardiovascular disease, neoplasias, complex ovarian disease, liver disease, kidney disease, blood disease, neurological or endocrine-metabolic disease) which as judged by the investigator, may be inappropriate for inclusion of patients in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to 24 weeks in frequency of hot flushes as recorded by patient in a daily diary | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in bone marker levels (P1NP, CTX-1, NTX and BSAP) from baseline to 12 and 24 weeks 2. Change in Vaginal Maturation Index (VMI) from baseline to 12 and 24 weeks 3. Mean change from baseline to 4, 8, 12 and 24 weeks in severity of hot flushes 4. Mean change from baseline to 4, 8 and 12 weeks in frequency of hot flushes 5. Quality of life measured by Women's Health Questionnaire 6. Change in lab test results and clinical parameters | — |
Countries
Brazil
Outcome results
None listed