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Venous ThrombosisPhase 4OPTIMISENCT02264743

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

A Phase 4 study testing Femoston Conti and EVOREL® CONTI in people with Venous Thrombosis and Insulin Resistance, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Venous Thrombosis, Insulin Resistance
What is being tested?
Femoston Conti and EVOREL® CONTI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesUnited Kingdom
Study dates
Nov 2013to Nov 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

John Stevenson, MBBS contact

0207 351 8112

j.stevenson@imperial.ac.uk

Marie Gerval, MBBS contact

07734386042

m.gerval@imperial.ac.uk

United Kingdom3 sites, 3 recruiting

  • Chelsea and Westminster NHS Foundation Trust

    London, SW10 9NH

    Nick Panay, MBBS, MRCOG, 0203 331 8112, n.panay@imperial.ac.uk

    Nick Panay, MBBS,MRCOG

    Recruiting

  • Royal Brompton and Harefield NHS Trust

    London, SW3 6NP

    John Stevenson, MBBS

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

    Nick Panay, MBBS, MRCOG, 0203 331 8112, n.panay@imperial.ac.uk

    Nick Panay, MBBS, MRCOG

    Recruiting

Other trials in United Kingdom

About this study

Official title: Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease

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.

Read the 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.

Being tested
Femoston Conti, EVOREL® CONTI
Medical subject headings
Venous Thrombosis, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Femoston ContiDrug

    Also called Femoston Conti 0.5mg/2.5mg film-coated tablets versus

    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

  • EVOREL® CONTIDrug

    Also called Evorel Conti transdermal patch 25 mcg transdermal dose

    Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch

Study groups in NCT02264743
Study groupRoleWhat they receive
Femoston Conti 0.5mg/2.5mgExperimentalUltra 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
Receives: Drug: Femoston Conti
EVOREL® CONTI transdermal patchesActive comparatorEVOREL 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
Receives: Drug: EVOREL® CONTI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thrombin Generation IU/DL

    Measured: Six months

Secondary outcomes (11)

  1. triglycerides

    mmol/L

    Measured: 6 months

  2. HDL

    mmol/L

    Measured: 6 months

  3. Total cholesterol

    mmol/L

    Measured: 6 months

  4. LDL

    mmol/L

    Measured: 6 months

  5. D-Dimers

    ng/ml

    Measured: 6 months

  6. APC resistance

    >2 or <2

    Measured: 6 months

  7. fibrinogen

    g/L

    Measured: 6 months

  8. Factor V11

    U/ml

    Measured: 6 months

  9. PAI-1 protein

    nq/ml

    Measured: 6 months

  10. fasting insulin

    pmol/L

    Measured: 6 months

  11. fasting glucose

    mmol/L

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2014 (estimated)
  4. Study completionNov 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264743
Sponsor's protocol ID
2013MM002B
Other IDs
2013-002094-22
Acronym
OPTIMISE
Status last verified
Oct 2014
First submitted
20 Dec 2013
Last updated
15 Oct 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Femoston Conti and EVOREL® CONTI in people with Venous Thrombosis and Insulin Resistance, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact John Stevenson, MBBS (0207 351 8112, j.stevenson@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thrombin Generation IU/DL (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02264743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.

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