A randomised controlled trial to compare the effect of 2 progesterones on the vascular elasticity, lipid profiles and coagulation cascade (clotting factors) of women with premature ovarian failure.

Phase 1

• Conditions: Premature ovarian failure.; MedDRA version: 14.1 Level: LLT Classification code 10036602 Term: Premature ovarian failure System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-004511-30-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-27
• Study Completion: 2016-09-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

1. Females aged between 16 and up to 45 years.
2. Confirmed diagnosis of POF with a history of oligomenorrhoea/amenorrhoea for at least 6 months and elevated gonadotrophins = 30mlU/ml on two separate occasions.
3. Willingness to participate.
4. No concomitant co-morbidities that would contraindicate the use of hormonal preparations such as unexplained bleeding, breast cancer, endometrial cancer or thromboembolic disease.
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age under 16 or over 45 years.
2.Pregnant or lactating females.
3.Contraindication to the use of hormonal preparations, such as a history of cerebrovascular disease and thromboembolic disease.
4.Factors present in the past medical history that would contribute to the increased risk of cardiovascular disease, such as, previous myocardial infarction, angina, diabetes, kidney disease, hyperlipidaemia or hypertension.
5.Personal history of thromboembolic episode or known thrombophilia that would impact on the results of the thrombogenic profile.
6.Presence of any other clinically significant medical condition, as determined by the investigators.
7.Known Porphyria.
8.Known liver disease.
9.Known past or suspected breast cancer.
10.Undiagnosed vaginal bleeding.
11.Genital tract carcinoma.
12.Thrombophlebitis.
13.Smokers.
14.Body mass index >35.
15.Known hypertensive disease.
16.Women on concomitant medications that could influence the results, such as anti-hypertensives or anticoagulants.
17.Known intolerance, allergy or contraindication to the use of oestrogen and/or progesterone.
18.Known hypersensitivity to the active substances or excipients contained within the utrogestan, Medroxyprogesterone Acetate or Evorel patches
19.Known allergy to peanuts or soya.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified