Menopausal transition and prospects of treatment

Supplementation with alpha lipoic acid and hormone therapy with tibolone in menopausal transition: impact on oxidative stress, bone mass and quality of life.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000200987

Enrollment

200

Registered

2011-02-21

Start date

2008-10-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To value the impact of lipoic acid supplementation and treatment with Tibolone on the condition of oxidative stress, climateric symptoms and quality of life in women in the menopausal transition.

Interventions

The trial was conducted as a prospective, randomized, placebo-controlled, double-blind. Eligible participants were randomized into four groups: The control group(G1) - consisting of 35 participants received capsules containing placebo - microcellulose capsule; The Tibolone Group(G2) - consisting of 30 participants received capsules containing 2.5 mg tibolone per day(Reduclin (Registered Trademark) 2.5 mg, produced by Farmoquimica S/A, Rio de Janeiro, Brazil, registered in the Ministry of health science of Brazil number 1.0390.0136-001); The alpha lipoic acid group(G3) - consisting of 32 participants received capsules containing 600 mg of alpha lipoic acid per day; The tibolone and alpha lipoic group(G4) consisting of 32 participants received capsules containing 2.5 mg of tibolone per day and 600 mg of alpha lipoic acid per day. This study lasted 12 weeks. Participants were assessed at baseline, 4, 8 and 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to 55 Years

Healthy volunteers

Yes

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/L

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.

Outcome results