Menopausal transition and prospects of treatment

Phase 4

Completed

• Conditions: climacteric syndrome; menopause; Reproductive Health and Childbirth - Menstruation and menopause; Alternative and Complementary Medicine - Other alternative and complementary medicine; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12611000200987
• Lead Sponsor: niversidade Federal do Rio Grande do Norte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Menstrual irregularity and/ or less than 12 months amenorrhea;;
Scoring less than 14 points in the Menopausal Index Blatt and Kupperman;
Serum concentrations of FSH >30 IU/

Exclusion Criteria

a)prior hormone therapy(HT) ; b) amenorrhea for more than 12 months c) early menopause(before age 40 years) or surgical menopause(hysterectomy or bilateral oophorectomy) d)the presence of systemic diseases (cardiovascular disease, diabetes, hypertension, cerebrovascular disease, thromboembolic disease, hepatic, or renal failure); e) the presence of osteoporosis; f) the presence of contraindications to HT (endometrial hyperplasia, malignant breast disease, endometrium cancer, undiagnosed vaginal bleeding); g) the presence of acute infection or chronic inflammatory disease; h)the use of drugs that could affect the metabolism (b-blockers, glucocorticoids, diuretics, lipid lowering drugs, antidiabetics, antiresorptives, anticoagulants); i) Smokers; j) the use of alcohol or drug abuse; l)Body Mass Index> 35 kg / m²; m)endometrial thickness on transvaginal ultrasound> 15 mm; n)Results of Cytopathology oncotic previous or current diagnoses of atypia of undetermined significance , high grade intraepithelial lesions, microinvasive carcinoma and cervical cancer; o)Presents some contraindication to therapy with tibolone; p) Medical conditions not listed but which may interfere with the climacteric; q) Fears, real or anticipated claims for treatment that might interfere with the objectives of the study; r)Simultaneous participation in another clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Climacterics Symptoms[The Kupperman Index(IMK) and Greene Climacteric Scale was determined at each visit. They were detected before treatement(baseline), at weeks 4 and 8(during treatment) and at week 12(end of treatment).];Activity of blood antioxidant enzymes: glutathione peroxidase, superoxide dismutase, catalase and thiobarbituric acid reactive substances.[Glutathione peroxidase activity was determined using quantitative and qualitative characterization of erythrocyte glutathione reductase. Superoxide dismutase activity and catalase were determined spectrophotometrically. Serum thiobarbituric acid reactive substances levels were calculated using a molar absorption coefficient. They were detected before treatment(baseline) and at week 12(end of treatment).];Quality of life before and after treatment.[Utian Quality of Life - Menopause - UQol. They were detected before treatment(baseline), at weeks 4 and 8 (during treatment) and at week 12(end of treatment).]