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Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy (OPTIMISE)

Primary Purpose

Venous Thrombosis, Insulin Resistance

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Femoston Conti
EVOREL® CONTI
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thrombosis

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy and postmenopausal woman who have had a normal ultrasound result
  • Aged 40 - 60 years
  • At least 1 year post last menstrual period (per participant report)
  • BMI 18 - 32
  • Normal mammogram within 2 years of study commencement
  • Continue on any concomitant medications without any change during the study give informed consent

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, antiandrogens,
  • PDE5 inhibitors, DHEA, SERMS)
  • Have a significant psychiatric disorder
  • Have a history of breast or oestrogen dependent cancer
  • Have diabetes, thrombo-embolic disorders (recent MI angina DVT varicose veins or recurrent DVT), cardiovascular disease, liver disease any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
  • Untreated endometrial hyperplasia
  • Dubin-Johnson syndrome and Rotor syndrome
  • Undiagnosed vaginal bleeding
  • Women who have had a hysterectomy

Sites / Locations

  • Chelsea and Westminster NHS Foundation TrustRecruiting
  • Royal Brompton and Harefield NHS TrustRecruiting
  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Femoston Conti 0.5mg/2.5mg

EVOREL® CONTI transdermal patches

Arm Description

Ultra low dose, film-coated 17β-estradiol (as hemihydrate) 0.5mg & dydrogesterone 2.5 mg Once a day The duration is six months. Drug intervention: Estradiol&DydrogesteronevsOestradiol&Norethisterone acetate

EVOREL CONTI is a transdermal self adhesive patch which is 0.1 mm in thickness and each patch releases 50mcg of oestradiol and 170mcg of norethisterone acetate over 24 hours . The Evorel Conti patch is cut in half and applied to the lower part of the body for 3.5 days (delivering approx 25mcg of oestradiol over 24 hours ) this is replaced every 3.5 days . The duration is six months. Drug intervention: Estradiol&DydrogesteronevsOestradiol&Norethisterone acetate

Outcomes

Primary Outcome Measures

Thrombin Generation IU/DL

Secondary Outcome Measures

triglycerides
mmol/L
HDL
mmol/L
Total cholesterol
mmol/L
LDL
mmol/L
D-Dimers
ng/ml
APC resistance
>2 or <2
fibrinogen
g/L
Factor V11
U/ml
PAI-1 protein
nq/ml
fasting insulin
pmol/L
fasting glucose
mmol/L

Full Information

First Posted
December 20, 2013
Last Updated
October 14, 2014
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Chelsea and Westminster NHS Foundation Trust, Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02264743
Brief Title
Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy
Acronym
OPTIMISE
Official Title
Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Chelsea and Westminster NHS Foundation Trust, Imperial College Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ultra-low-dose oral E2/D will have more beneficial effects than trans-dermal HRT on lipids and insulin resistance in postmenopausal women, whilst adverse effects on coagulation will be avoided.
Detailed Description
Following screening for eligibility, women will be studied at baseline and then randomized to one of two groups: Group A administered Femoston Conti - oral oestradiol 17β 0.5 mg/dydrogesterone 2.5 mg daily for the duration of the treatment phase (24 weeks) Group B administered ½ Evorel Conti patches - trans-dermal Estradiol 25 mcg/norethisterone acetate 85 mcg (½ Evorel Conti patches) daily for the duration of the treatment phase (24 weeks). Studies will be repeated after 6 months of therapy at the follow up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Femoston Conti 0.5mg/2.5mg
Arm Type
Experimental
Arm Description
Ultra low dose, film-coated 17β-estradiol (as hemihydrate) 0.5mg & dydrogesterone 2.5 mg Once a day The duration is six months. Drug intervention: Estradiol&DydrogesteronevsOestradiol&Norethisterone acetate
Arm Title
EVOREL® CONTI transdermal patches
Arm Type
Active Comparator
Arm Description
EVOREL CONTI is a transdermal self adhesive patch which is 0.1 mm in thickness and each patch releases 50mcg of oestradiol and 170mcg of norethisterone acetate over 24 hours . The Evorel Conti patch is cut in half and applied to the lower part of the body for 3.5 days (delivering approx 25mcg of oestradiol over 24 hours ) this is replaced every 3.5 days . The duration is six months. Drug intervention: Estradiol&DydrogesteronevsOestradiol&Norethisterone acetate
Intervention Type
Drug
Intervention Name(s)
Femoston Conti
Other Intervention Name(s)
Femoston Conti 0.5mg/2.5mg film-coated tablets versus
Intervention Description
Ultra-low-dose oral E2/D [Oestradiol 17β 0.5mg/dydrogesterone 2.5 mg] oral Femoston Conti 0.5mg Estradiol&Dydrogesterone vs Oestradiol&Norethisterone acetate
Intervention Type
Drug
Intervention Name(s)
EVOREL® CONTI
Other Intervention Name(s)
Evorel Conti transdermal patch 25 mcg transdermal dose
Intervention Description
Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch
Primary Outcome Measure Information:
Title
Thrombin Generation IU/DL
Time Frame
Six months
Secondary Outcome Measure Information:
Title
triglycerides
Description
mmol/L
Time Frame
6 months
Title
HDL
Description
mmol/L
Time Frame
6 months
Title
Total cholesterol
Description
mmol/L
Time Frame
6 months
Title
LDL
Description
mmol/L
Time Frame
6 months
Title
D-Dimers
Description
ng/ml
Time Frame
6 months
Title
APC resistance
Description
>2 or <2
Time Frame
6 months
Title
fibrinogen
Description
g/L
Time Frame
6 months
Title
Factor V11
Description
U/ml
Time Frame
6 months
Title
PAI-1 protein
Description
nq/ml
Time Frame
6 months
Title
fasting insulin
Description
pmol/L
Time Frame
6 months
Title
fasting glucose
Description
mmol/L
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy and postmenopausal woman who have had a normal ultrasound result Aged 40 - 60 years At least 1 year post last menstrual period (per participant report) BMI 18 - 32 Normal mammogram within 2 years of study commencement Continue on any concomitant medications without any change during the study give informed consent 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, antiandrogens, PDE5 inhibitors, DHEA, SERMS) Have a significant psychiatric disorder Have a history of breast or oestrogen dependent cancer Have diabetes, thrombo-embolic disorders (recent MI angina DVT varicose veins or recurrent DVT), cardiovascular disease, liver disease any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia Untreated endometrial hyperplasia Dubin-Johnson syndrome and Rotor syndrome Undiagnosed vaginal bleeding Women who have had a hysterectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Stevenson, MBBS
Phone
0207 351 8112
Email
j.stevenson@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Gerval, MBBS
Phone
07734386042
Email
m.gerval@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Stevenson, MBBS
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chelsea and Westminster NHS Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Panay, MBBS, MRCOG
Phone
0203 331 8112
Email
n.panay@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Nick Panay, MBBS,MRCOG
Facility Name
Royal Brompton and Harefield NHS Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Stevenson, MBBS
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Panay, MBBS, MRCOG
Phone
0203 331 8112
Email
n.panay@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Nick Panay, MBBS, MRCOG

12. IPD Sharing Statement

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Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy

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