Oral vs. Patch Trial in Menopause – Individualisation of oestrogen therapy

Phase 1

• Conditions: The effect of oestrogen replacement therapy taken either orally or transdermally and observing any likely benefit of both these therapies on the risks Venous thromobembolic events and cardiovascular heart disease.; MedDRA version: 16.1Level: HLGTClassification code 10027309Term: Menopause and related conditionsSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2013-002094-22-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

?Healthy and postmenopausal woman who have had a normal ultrasound result during the study screening visit (or obtained during routine clinical care and within 6 weeks of the visit taking place).

?aged 40 - 60 years
?at least 1 year post last menstrual period (per participant report)
?BMI 18 - 32
?Verbal confirmation of a normal mammogram within 2 years of study commencement
?continue on any concomitant medications without any change during the study
?give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Estrogen or androgen therapy during preceding 3 months
• use of hormone implants during the preceding 12 months
• have received any medications which may interfere with the study (SSRI, anti-androgens, PDE5 inhibitors, DHEA, SERMS)
• have a significant psychiatric disorder
• have a history of breast cancer
• have diabetes, thrombo-embolic disorders, cardiovascular disease, any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified