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Nanostructured Transdermal HRT for Menopausal Symptoms
NCT02033512Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2003
- Primary completion
- Jan 2004
- Countries
- 1
- Sponsor
- Universidade Potiguar
- Modality
- Small Molecules
- Conditions
- menopause
01
Overview
Phase 2, randomised trial of estriol, estradiol and progesterone in menopause, sponsored by Universidade Potiguar. Primary endpoint: Estradiol Levels at 5 years. Started Jan 2003; status: completed.
02
Design
1 arm- Study design
- Randomized
Transdermal HRT
Transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) + Progesterone (10%) (Biolipid B2®)
03
Who it enrols
Postmenopausal women aged 51-70 with FSH > 35 IU/L and LMP 6 months to 3 years prior. Excludes patients with diabetes, history of cancer, thromboembolism, cardiovascular disease, or endometrial thickness > 5 mm.
04
Endpoints
Primary
Estradiol Levels
Secondary
Effect of Progesterone associated with Estriol + Estradiol Nanoparticles formulation on postmenopausal complaints
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