Long-Acting Reversible Contraception
Conditions
Interventions
This is an experimental, randomized, double-blind, placebo-controlled study that will evaluate the effect of Ulipristal Acetate in users of Etonogestrel implants with abnormal uterine bleeding. A tota
Sponsors
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
UNICAMP - Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women aged 18-45; etonogestrel implant users who experience prolonged or recurrent abnormal bleeding (bleeding lasting more than 14 days or episodes with intervals of less than 24 days)
Exclusion criteria
Exclusion criteria: Pregnant women; women who have given birth within the last six months, breastfeeding women; women with abnormal uterine bleeding of unknown cause prior to placement of the ENG implant; women with known pre-existing liver disease, women with blood dyscrasias; users of anticoagulants; users of medication that contraindicates the use of Ulipristal Acetate (vinblastine, digoxin, quinidine, dabigatran etexilate, phenytoin, barbiturates, loperamide, oxycarbamazepine, carbamazepine, rifampicin, griseofulvin, topiramate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the use of Ulipristal Acetate will be able to inhibit abnormal bleeding (number of days and number of episodes) in users of the implant with Etonogestrel by up to 6 days, whereas the placebo will not, as verified through menstrual diaries | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the use of ulipristal acetate will be able to reduce the endometrial thickness measured by transvaginal ultrasound to 4 millimeters or less after the end of treatment in users of the Etonogestrel implant, whereas the placebo will not, as verified by transvaginal ultrasound during the 30- and 180-day visits;The use of ulipristal acetate is not expected to cause clinically significant laboratory changes after the end of treatment in users of the implant with Etonogestrel within 6 days, as verified by laboratory tests collected at the baseline visit and at the 30-day visit | — |
Countries
Brazil
Contacts
Public ContactLuis Bahamondes
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
Outcome results
None listed