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

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ClinicalTrials.gov Identifier: NCT02264743
Recruitment Status : Unknown
Verified October 2014 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Collaborators:
Chelsea and Westminster NHS Foundation Trust
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date October 15, 2014
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
Thrombin Generation IU/DL [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
  • triglycerides [ Time Frame: 6 months ]
    mmol/L
  • HDL [ Time Frame: 6 months ]
    mmol/L
  • Total cholesterol [ Time Frame: 6 months ]
    mmol/L
  • LDL [ Time Frame: 6 months ]
    mmol/L
  • D-Dimers [ Time Frame: 6 months ]
    ng/ml
  • APC resistance [ Time Frame: 6 months ]
    >2 or <2
  • fibrinogen [ Time Frame: 6 months ]
    g/L
  • Factor V11 [ Time Frame: 6 months ]
    U/ml
  • PAI-1 protein [ Time Frame: 6 months ]
    nq/ml
  • fasting insulin [ Time Frame: 6 months ]
    pmol/L
  • fasting glucose [ Time Frame: 6 months ]
    mmol/L
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy
Official Title  ICMJE Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Venous Thrombosis
  • Insulin Resistance
Intervention  ICMJE
  • Drug: Femoston Conti
    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
    Other Name: Femoston Conti 0.5mg/2.5mg film-coated tablets versus
  • Drug: EVOREL® CONTI
    Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch
    Other Name: Evorel Conti transdermal patch 25 mcg transdermal dose
Study Arms  ICMJE
  • Experimental: Femoston Conti 0.5mg/2.5mg

    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

    Intervention: Drug: Femoston Conti
  • Active Comparator: EVOREL® CONTI transdermal patches

    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: Drug: EVOREL® CONTI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2015
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02264743
Other Study ID Numbers  ICMJE 2013MM002B
2013-002094-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor  ICMJE Royal Brompton & Harefield NHS Foundation Trust
Collaborators  ICMJE
  • Chelsea and Westminster NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
Investigators  ICMJE
Principal Investigator: John Stevenson, MBBS Royal Brompton & Harefield NHS Foundation Trust
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP