lipristal acetate versus conventional management of heavy menstrual bleeding

Phase 3

Completed

• Conditions: Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Menstrual Disorders; Urological and Genital Diseases

• Registration Number: ISRCTN20426843
• Lead Sponsor: HS Lothian

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37251622/ results (added 31/05/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37304815/ (added 12/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-25
• Study Completion: 2021-05-31
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 236

Inclusion Criteria

Current inclusion criteria as of 21/05/2020:
1. Aged 18 years or over
2. Menstrual bleeding that she perceives to be heavy and troublesome
3. Willing to receive medical treatment with either UPA or LNG-IUS
4. Willing to undergo two pelvic ultrasounds
5. 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)
6. If allocated to UPA mechanistic sub-study, willing and eligible to undergo three endometrial 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
7. Willing to use barrier contraception if allocated to UPA
8. Given written informed consent
9. 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

Previous inclusion criteria:
1. Females aged between 18 or over
2. Heavy menstrual bleeding at intervals of 25-42 days that she perceives to be heavy and troublesome
3. Willing to receive medical treatment with either UPA or LNGIUS
4. Willing to undergo two pelvic ultrasounds and at least one endometrial biopsy, but up to four if allocated to UPA
5. Willing to use barrier contraception if allocated to UPA
6. Given written informed consent
7. Willing to undergo one additional endometrial biopsy and at least three magnetic resonance imaging scan (if allocated to UPA, mechanistic substudy only)

Exclusion Criteria

Current exclusion criteria as of 21/05/2020:
1. Post-menopausal
2. A >14 week fibroid uterus and/or cavity length >11 cm confirmed by ultrasound scan
3. Submucosal fibroids >2cm diameter confirmed by ultrasound scan
4. Contraindications to UPA or LNG-IUS
5. Intention to continue current use of Cytochrome P450 (CYP3A4) inhibitors
6. Intention to continue current use of Cytochrome P450 (CYP3A4) inducers (e.g. Phenytoin, carbamazepine, rifampicin, St John’s Wort)
7. Intention to continue current use of P-glycoprotein substrates (e.g. digoxin)
8. A past, current or suspected diagnosis of endometrial hyperplasia or neoplasia
9. History of liver problems
10. Exclusion from the trial or initiating a new course of UPA if Alanine transaminase (ALT) or aspartate aminotransferase (AST) more than 2-times the upper limit of normal (ULN)
11. Epilepsy managed with carbamazepine, phenytoin
12. Significant renal impairment
13. Pregnant
14. Current plans to become pregnant within 12 months
15. Currently breastfeeding
16. Severe asthma that is not sufficiently controlled by oral glucocorticoids
17. Past or current known history of with uterine, cervical, ovarian or breast cancer.
18. Current use of progestagen-releasing intrauterine device (except if allocated within UCON)
19. Intention to continue regular use of Mefenamic acid
20. Intention to continue regular use of Tranexamic acid
21. Intention to continue regular use of GnRH analogues
22. Intention to continue regular use of Progestagen-only contraceptive
23. Intention to continue regular use of any combined oral contraceptive pills
24. Intention to continue regular use of hormonal replacement therapy

Previous exclusion criteria:
1. A >14 week fibroid uterus and/or cavity length >11 cm confirmed by ultrasound scan
2. Submucosal fibroids >2cm diameter confirmed by ultrasound scan
3. Contraindications to UPA or LNGIUS
4. Current use of Cytochrome P450 (CYP3A4) inhibitors
5. Current use of Cytochrome P450 (CYP3A4) inducers
6.Current use of Pglycoprotein substrate (e.g.digoxin)
7. A past, current or suspected diagnosis of endometrial hyperplasia or endometrial neoplasia
8. Severe hepatic impairment
9. Suffer with epilepsy managed with carbamazepine, phenytoin
10. Significant renal impairment
11. Pregnant
12. Current plans to become pregnant within 12 months
13. Currently breastfeeding
14. Severe asthma that is not sufficiently controlled by oral glucocorticoidssteroids
15. Suffer with uterine, cervical, ovarian or breast cancer
16. Receiving Pglycoprotein substrates
17. Current use of progestagen releasing intrauterine device (except if allocated within UCON)
18. Continued regular use of Mefenamic acid
19. Continued regular use of Tranexamic acid
20. Continued regular use of GnRH analogues
21. Continued regular use of Progestagen only contraceptive
22. Continued regular use of any combined oral contraceptive pills

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the condition-specific Menorrhagia Multi-Attribute Scale (MMAS) designed and validated to capture the impact of HMB on women’s day-to-day life.