drugset / Trial / NCT02361892

The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve

NCT02361892

Phase 4 Unknown 73 enrolled University Magna Graecia
NaSingle-groupOpen-labelTreatment

Summary

The uterine leiomyoma is the most common female benign disease.UPA seems to be most effective for the medical management of fibroids and could be place as preoperative adjunct to surgery but also as medical therapy to avoid surgery. No data have been published about the effect of UPA on FSH (Follicle stimulating hormone) or AMH levels nor on ovarian antral follicle count (AFC) or vascularization indexes during and after treatment. Considering that in young women of reproductive age (under 40 years old), desiring pregnancy, UPA has been proposed to avoid or postpone surgery, also in a long-term administration program, data about its effect on women ovarian reserve are urgently needed. For these reasons, data on biochemical (AMH, FSH and E2) and 3D ultrasonographic (VI, Flow index, AFC) parameters of women treated by UP are needed to assess the effect of the drug in terms of ovarian reserve modification.

Timeline

Start
2015-02
Primary completion
2017-06
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulipristal Acetate Unknown 5 mg

Indications