Evaluating Prevention of Muscle Loss After Menopause Using Testosterone: The PAMELA study

Phase 4

• Conditions: Muscle loss; Osetopenia; sarcopenia; osteoporosis; Reproductive Health and Childbirth - Menstruation and menopause; Musculoskeletal - Osteoporosis; Musculoskeletal - Other muscular and skeletal disorders; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12623000166673
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-17
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 156

Inclusion Criteria

Naturally postmenopausal women, aged 55-70 years, who are not taking medications that might influence hormone levels or muscle/bone health. Participants must be agreeable to taking vitamin D3 1000 IU/day and making no meaningful change in their exercise regime or diet over the course of the study. Participants will be required to have a body mass index between 18 and 35 kg/m2, a clinically acceptable mammogram in the preceding 2 years and clinically acceptable cervical screening test results within the preceding 5 years.

Exclusion Criteria

1.Body mass index <18 or >35 kg/m2
2.Current or recent (in the past 12 months) use of systemic estrogen replacement therapy or tibolone (vaginal estrogen permitted)
3.Current or recent (in the past 12 months) use of antiandrogens
4.Use of any drugs affecting bone metabolism such as bisphosphonates, denosumab, systemic corticosteroids, antineoplastic drugs, thiazide diuretics, anti-epileptic drugs, and heparin in the last 5 years
5.History of testosterone or dehydroepiandrosterone treatment in the last 5 years
6.Plans to commence a weight reduction diet for the duration of the study
7.Known allergy to almonds (a constituent of the cream)
8.Severe chronic skin disease (such as eczema or psoriasis) that is likely to interfere with transdermal drug absorption
9.Intolerance to transdermal testosterone
10.Clinically significant infection requiring systemic antibiotics
11.Undiagnosed vaginal bleeding
12.Evidence of clinical hyperandrogenism (hirsutism, androgenic alopecia, or acne) as assessed by the recruiting clinician
13.Taking herbal remedies, grapefruit juice, or medications known to be strong inducers or inhibitors of cytochrome P450 3A4 or known to interact with testosterone metabolism or reproductive hormone levels.
14.Use of protein supplementation is permitted but participants will be restricted from commencing new any new protein supplement or increasing their consumption.
15.History of smoking within the past year, active substance abuse, or alcohol consumption of more than two standard drinks per day
16.Severe musculoskeletal, neurological, or metabolic disease which might influence the results of the study
17.Present or previous systemic cancer diagnosis in the last 5 years
18.Donation of blood within the last 6 weeks or plasma within 7 days of the first dosing in this study
19.Abnormal thyroid function (abnormal thyroid stimulating hormone (TSH) value confirmed by a free T4 outside laboratory range)
20.Being considered by a chief investigator to be unsuitable for participation in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any change in body-weight corrected power (W/kg) during a two leg countermovement jump measured via the Leonardo Mechanography Ground Reaction Force Platform.[6 months post-randomisation.]