NCT02264743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

December 20, 2013

Last Update Submit

October 14, 2014

Conditions

Venous ThrombosisInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Thrombin Generation IU/DL

    Six months

Secondary Outcomes (11)

  • triglycerides

    6 months

  • HDL

    6 months

  • Total cholesterol

    6 months

  • LDL

    6 months

  • D-Dimers

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Femoston Conti 0.5mg/2.5mg

EXPERIMENTAL

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

EVOREL® CONTI transdermal patches

ACTIVE COMPARATOR

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

Interventions

Femoston ContiDRUG

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

Also known as: Femoston Conti 0.5mg/2.5mg film-coated tablets versus
Femoston Conti 0.5mg/2.5mg
EVOREL® CONTIDRUG

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

Also known as: Evorel Conti transdermal patch 25 mcg transdermal dose
EVOREL® CONTI transdermal patches

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chelsea and Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

RECRUITING

Royal Brompton and Harefield NHS Trust

London, SW3 6NP, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Venous ThrombosisInsulin Resistance

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • John Stevenson, MBBS

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Stevenson, MBBS

CONTACT

0207 351 8112j.stevenson@imperial.ac.uk

Marie Gerval, MBBS

CONTACT

07734386042m.gerval@imperial.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

October 15, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

GB(3)