Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02361892
Status:
UNKNOWN
Last Update Posted:
2016-11-18
First Post:
2015-02-02
Brief Title:
The Effect of Ulipristal Acetate UPA on Women Ovarian Reserve
Sponsor:
University Magna Graecia
Organization:
University Magna Graecia
Study Overview
Official Title:
The Effect of UPA on Women Ovarian Reserve
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPA_ovAge
Brief Summary:
The uterine leiomyoma is the most common female benign diseaseUPA 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
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
Detailed Description:
The uterine leiomyoma is the most common benign tumor of the female genital tract The myomas are usually clinically apparent in 25 of patients Among the latest possible therapeutic options UPA has proved to be most effective for the medical management of fibroids Its advent in the clinical practice will probably modify the surgical approach since UPA could possible place as a preoperative adjunct to surgery but also as medical therapy to avoid surgery Very recently the results of the first study on long-term intermittent 18 months therapy with 10-mg UPA were published demonstrating that this regimen four courses of 3 months maximizes the effect of UPA by inducing a very high rate of amenorrhea and reducing fibroid size
Long term treatment however call in question safety issue that need to be explore In patients treated by UPA Estradiol under 5-mg and 10-mg doses remained at midfollicular levels after the first course of therapy avoiding menopausal symptoms as frequently observed in the gonadotropin-releasing hormone GnRH- agonist group No data have been published about Estradiol levels at the end of second third and fourth courses of UPA Moreover no data have been published about the effect of UPA on FSH 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 FI AFC parameters of women treated by UP are needed to assess the effect of the drug in terms of ovarian reserve modification
Long term treatment however call in question safety issue that need to be explore In patients treated by UPA Estradiol under 5-mg and 10-mg doses remained at midfollicular levels after the first course of therapy avoiding menopausal symptoms as frequently observed in the gonadotropin-releasing hormone GnRH- agonist group No data have been published about Estradiol levels at the end of second third and fourth courses of UPA Moreover no data have been published about the effect of UPA on FSH 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 FI AFC parameters of women treated by UP are needed to assess the effect of the drug in terms of ovarian reserve modification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None