A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system.
Adult
Brazil
Contraceptive Agents, Female
/ administration & dosage
Double-Blind Method
Female
Humans
Intrauterine Devices, Medicated
/ adverse effects
Levonorgestrel
/ administration & dosage
Norpregnadienes
/ administration & dosage
Pilot Projects
Uterine Hemorrhage
/ chemically induced
Young Adult
Abnormal bleeding
Levonorgestrel intrauterine system
Randomized clinical trial
Treatment
Ulipristal acetate
Journal
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
ISSN: 1879-3479
Titre abrégé: Int J Gynaecol Obstet
Pays: United States
ID NLM: 0210174
Informations de publication
Date de publication:
Apr 2020
Apr 2020
Historique:
received:
17
07
2019
revised:
27
10
2019
accepted:
26
11
2019
pubmed:
30
11
2019
medline:
7
7
2020
entrez:
29
11
2019
Statut:
ppublish
Résumé
To assess the efficacy of ulipristal acetate (UPA) for reducing abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system (LNG-IUS). A randomized, double-blind, placebo-controlled pilot study conducted from September 1, 2016 to September 30, 2018, at the University of Campinas, Brazil. LNG-IUS users reporting prolonged or frequent uterine bleeding for at least 1 year were randomized to receive 5 mg UPA per day for 5 days or placebo at an identical regimen. Bleeding was recorded for 90 days after treatment began and was compared between the groups. Of 94 eligible women, 64 with abnormal bleeding associated with LNG-IUS use declined treatment or device removal after counselling regarding anticipated bleeding patterns. For the 25 study participants, differences were nonsignificant between the UPA and placebo groups for number of days before bleeding stopped and days free of bleeding; however, UPA users displayed a trend for shorter duration before bleeding stopped and longer time free of bleeding. A similar trend for mean number of bleeding days at 30-, 60-, and 90-day follow-up was observed. A nonsignificant trend in reduction of abnormal bleeding was observed among LNG-IUS users taking 5 mg UPA per day for 5 days compared with placebo; however, further research is needed. CLINICALTRIALS.GOV: NCT03186586.
Substances chimiques
Contraceptive Agents, Female
0
Norpregnadienes
0
Levonorgestrel
5W7SIA7YZW
ulipristal acetate
YF7V70N02B
Banques de données
ClinicalTrials.gov
['NCT03186586']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
10-15Subventions
Organisme : Fundação de Apoio à Pesquisa do Estado de São Paulo (FAPESP)
Organisme : National Research Council (CNPq)
Organisme : International Contraceptive Access Foundation
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 International Federation of Gynecology and Obstetrics.
Références
Luukkainen T. Levonorgestrel-releasing intrauterine device. Ann N Y Acad Sci. 1991;626:43-49.
Sitruk-Ware R, Inki P. The levonorgestrel intrauterine system: Long-term contraception and therapeutic effects. Womens Health (Lond). 2005;1:171-182.
Pakarinen P, Luukkainen T, Laine H, Lähteenmäki P. The effect of local intrauterine levonorgestrel administration on endometrial thickness and uterine blood circulation. Hum Reprod. 1995;10:2390-2394.
Guttinger A, Critchley HO. Endometrial effects of intrauterine levonorgestrel. Contraception. 2007;6(Suppl):S93-S98.
Carvalho NM, Chou V, Modesto W, Margatho D, Garcia EAL, Bahamondes L. Relationship between user satisfaction with the levonorgestrel-releasing intrauterine system and bleeding patterns. J Obstet Gynecol Res. 2017;43:1732-1737.
Modesto W, Bahamondes MV, Bahamondes L. A randomized clinical trial of the effect of intensive versus non-intensive counselling on discontinuation rates due to bleeding disturbances of three long-acting reversible contraceptives. Hum Reprod. 2014;29:1393-1399.
Backman T, Huhtala S, Luoto R, Tuominen J, Rauramo I, Koskenvuo M. Advance information improves user satisfaction with the levonorgestrel intrauterine system. Obstet Gynecol. 2002;99:608-613.
Heikinheimo O, Inki P, Schmelter T, Tuominen J, Rauramo I, Koskenvuo M. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: Results of a prospective 5-year study. Hum Reprod. 2014;29:1182-1188.
Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)-a multicentre prospective study. Hum Reprod. 2010;25:354-359.
Suvisaari J, Lahteenmaki P. Detailed analysis of menstrual bleeding patterns after postmenstrual and postabortal insertion of a copper IUD or a levonorgestrel-releasing intrauterine system. Contraception. 1996;54:201-208.
Sordal T, Inki P, Draeby J, O'Flynn M, Schmelter T. Management of initial bleeding or spotting after levonorgestrel-releasing intrauterine system placement: A randomized controlled trial. Obstet Gynecol. 2013;121:934-941.
Lal S, Kriplani A, Kulshrestha V, Sharma M, Agarwal N. Efficacy of mifepristone in reducing intermenstrual vaginal bleeding in users of the levonorgestrel intrauterine system. Int J Gynecol Obstet. 2010;109:128-130.
Warner P, Guttinger A, Glasier A, et al. Randomized placebo-controlled trial of CDB-2914 in new users of a levonorgestrel-releasing intrauterine system shows only short-lived amelioration of unscheduled bleeding. Hum Reprod. 2010;25:345-353.
Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003;68:1013-1017.
Levy DP, Jager M, Kapp N, Abitbol JL. Ulipristal acetate for emergency contraception: Postmarketing experience after use by more than 1 million women. Contraception. 2014;89:431-433.
Talaulikar VS, Manyonda IT. Ulipristal acetate: A novel option for the medical management of symptomatic uterine fibroids. Adv Ther. 2012;29:655-663.
Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012;366:409-420.
Woodhead N, Pounds R, Irani S, Pradhan P. Ulipristal acetate for uterine fibroids: 2 years of real world experience in a UK hospital. J Obstet Gynecol. 2018;38:813-817.
Donnez J, Tomaszewski J, Vázquez F, et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012;366:421-432.
Barlow DH, Lumsden MA, Fauser BC, Terrill P, Bestel E. Individualized vaginal bleeding experience of women with uterine fibroids in the PEARL I randomized controlled trial comparing the effects of ulipristal acetate or placebo. Hum Reprod. 2014;29:480-489.
Zigler RE, Madden T, Ashby C, Wan L, McNicholas C. Ulipristal Acetate for unscheduled bleeding in Etonogestrel implant users: A randomized controlled trial. Obstet Gynecol. 2018;132:888-894.
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomized trials. J Clin Epidemiol. 2010;63:e1-e37.
Phupong V, Sophonsritsuk A, Taneepanichskul S. The effect of tranexamic acid for treatment of irregular uterine bleedibg secondary to Norplant use. Contraception. 2006;73:253-256.
Cohen MA, Simmons KB, Edelman AB, Jensen JT. Tamoxifen for the prevention of unscheduled bleeding in new users of the Levonorgestrel 52 mg intrauterine system: A randomized controlled trial. Contraception. 2019, in press.