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Trial record 12 of 265 for:    Estrogen Resistance

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

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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Insulin Resistance Drug: Femoston Conti Drug: EVOREL® CONTI Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease
Study Start Date : November 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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

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




Primary Outcome Measures :
  1. Thrombin Generation IU/DL [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. triglycerides [ Time Frame: 6 months ]
    mmol/L

  2. HDL [ Time Frame: 6 months ]
    mmol/L

  3. Total cholesterol [ Time Frame: 6 months ]
    mmol/L

  4. LDL [ Time Frame: 6 months ]
    mmol/L

  5. D-Dimers [ Time Frame: 6 months ]
    ng/ml

  6. APC resistance [ Time Frame: 6 months ]
    >2 or <2

  7. fibrinogen [ Time Frame: 6 months ]
    g/L

  8. Factor V11 [ Time Frame: 6 months ]
    U/ml

  9. PAI-1 protein [ Time Frame: 6 months ]
    nq/ml

  10. fasting insulin [ Time Frame: 6 months ]
    pmol/L

  11. fasting glucose [ Time Frame: 6 months ]
    mmol/L



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264743


Contacts
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Contact: John Stevenson, MBBS 0207 351 8112 j.stevenson@imperial.ac.uk
Contact: Marie Gerval, MBBS 07734386042 m.gerval@imperial.ac.uk

Locations
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United Kingdom
Chelsea and Westminster NHS Foundation Trust Recruiting
London, United Kingdom, SW10 9NH
Contact: Nick Panay, MBBS, MRCOG    0203 331 8112    n.panay@imperial.ac.uk   
Sub-Investigator: Nick Panay, MBBS,MRCOG         
Royal Brompton and Harefield NHS Trust Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: John Stevenson, MBBS         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Nick Panay, MBBS, MRCOG    0203 331 8112    n.panay@imperial.ac.uk   
Sub-Investigator: Nick Panay, MBBS, MRCOG         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Chelsea and Westminster NHS Foundation Trust
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: John Stevenson, MBBS Royal Brompton & Harefield NHS Foundation Trust

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02264743     History of Changes
Other Study ID Numbers: 2013MM002B
2013-002094-22 ( EudraCT Number )
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Insulin Resistance
Estrogens
Thrombosis
Venous Thrombosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone Acetate
Estradiol
Polyestradiol phosphate
Dydrogesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins
Contraceptives, Oral, Synthetic
Contraceptives, Oral