Trial to evaluate the effect of low-dose hormone therapy on menopausal symptoms and markers of bone turnover in postmenopausal wome

Not Applicable

Completed

• Conditions: Climateric symptoms; Urological and Genital Diseases; Menopausal and female climacteric states

• Registration Number: ISRCTN76005731
• Lead Sponsor: IBBS Farmaceutica Ltd (Brazil)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-11
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

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

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) - <4 weeks
6.2. Transdermal therapy (gel, patch), nasal spray - <4 weeks
6.3. Estrogen therapy/estrogen-progestogen oral SERM (Raloxifene), Tibolone, Androgens - <8 weeks
6.4. Intra-uterine therapy (Mirena) - <8 weeks
6.5. Combined injectable therapy, progestin implant (Implanon) - <3 months
6.6. Estrogenic implant (Riselle) or progestin injection (Depo-Provera) - <6 months
7. Use of medications with known effects on vasomotor symptoms such as selective serotonin-norepinephrine reuptake inhibitor (SSRIs), clonidine, gabapentin, tibolone, methyldopa and phytoestrogens in the last 30 days
8. Use of medications with known effects on bone metabolism such as glucocorticoids, gonadotropin-releasing hormone (GnRH) analogues, anticonvulsants, anticoagulants, immunosuppressive drugs, lithium, thyroxine, calcitonin and bisphosphonates within the last year
9. History or suspected uterine cancer, including endometrial hyperplasia and cancer
10. Abnormal genital bleeding unknown cause in the last 6 months
11. History or suspected breast cancer, ovarian cancer or estrogen-dependent neoplasia
12. Suspected mammography changes for breast cancer that require further investigation (simple cysts confirmed by breast ultrasound are be allowed)
13. History of conditions that affect bone metabolism, such as hypogonadism, gastrointestinal disturbances and hyperparathyroidism
14. History of diabetes mellitus (inclusion of patients with controlled diabetes - glycated hemoglobin <8% at screening ¨C is allowed)
15. History of thyroid disease with abnormal thyroid function (except for subclinical hypothyroidism)
16. History of hypertension with systolic blood pressure > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to 24 weeks in frequency of hot flushes as recorded by patient in a daily diary

Secondary Outcome Measures

Name	Time	Method
1. Changes in bone marker levels (P1NP, CTX-1, NTX and BSAP) from baseline to 12 and 24 weeks<br>2. Change in Vaginal Maturation Index (VMI) from baseline to 12 and 24 weeks<br>3. Mean change from baseline to 4, 8, 12 and 24 weeks in severity of hot flushes<br>4. Mean change from baseline to 4, 8 and 12 weeks in frequency of hot flushes<br>5. Quality of life measured by Women's Health Questionnaire<br>6. Change in lab test results and clinical parameters