Comparison of drug ulipristal acetate with existing treatment of levonorgestrel-releasing intra-uterine system.

Phase 1

• Conditions: Heavy menstrual bleeding; MedDRA version: 18.0Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864; MedDRA version: 18.0Level: PTClassification code 10027313Term: MenorrhagiaSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-003408-65-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-02
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

•Aged 18 years or over
•Menstrual bleeding at intervals of 21-42 days that she perceives to be heavy and troublesome
•Willing to receive medical treatment with either UPA or LNG-IUS
•Willing to undergo two pelvic ultrasounds
•If allocated to UPA, willing and eligible to undergo two endometrial biopsies with the possibility of a third and fourth (i.e. up to four biopsies)
•If allocated to UPA mechanistic sub-study, willing and eligible to undergo three biopsies with the possibility of a fourth and fifth (i.e. up to five biopsies). If ‘No’ may be randomised to RCT if UPA endometrial biopsy consent given
•Willing to use barrier contraception if allocated to UPA
•Given written informed consent
•Willing and eligible to undergo up to three magnetic resonance imaging scans? If allocated to UPA, mechanistic sub-study only. If ‘No’ may still be randomised to RCT

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 219
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

•Post-menopausal
•A >14 week fibroid uterus and/or cavity length >11 cm confirmed by ultrasound scan
•Submucosal fibroids >2cm diameter confirmed by ultrasound scan
•Contraindications to UPA or LNG-IUS
•Intention to continue current use of current use of Cytochrome P450 (CYP3A4) inhibitors
•Intention to continue current use of current use of Cytochrome P450 (CYP3A4) inducers (e.g. Phenytoin, carbamazepine, rifampicin, St John’s Wort)
•Intention to continue current use of P-glycoprotein substrates (e.g. digoxin)
•A past, current or suspected diagnosis of endometrial hyperplasia or neoplasia
•Severe hepatic impairment
•Epilepsy managed with carbamazepine, phenytoin
•Significant renal impairment
•Pregnant
•Current plans to become pregnant within 12 months
•Currently breastfeeding
•Severe asthma that is not sufficiently controlled by oral glucocorticoids
•Past or current known history of with uterine, cervical, ovarian or breast cancer.
•Current use of progestagen-releasing intrauterine device (except if allocated within UCON)
•Intention to continue regular use of Mefenamic acid
•Intention to continue regular use of Tranexamic acid
•Intention to continue regular use of GnRH analogues
•Intention to continue regular use of Progestagen-only contraceptive
•Intention to continue regular use of any combined oral contraceptive pills
•Intention to continue regular use of hormonal replacement therapy

Study & Design

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