Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-27 @ 3:14 AM
Study NCT ID:
NCT06174792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis
Sponsor:
University of Palermo
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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:
None
Brief Summary:
Adenomyosis is a common benign condition of fertile women and is characterized by dysmenorrhea, hypermenorrhea, abnormal uterine bleeding, infertility and chronic pelvic pain.
To date, no clear guidelines are available regarding the treatment of adenomyosis, however, resembling endometriosis, as it too is a sex hormone-dependent inflammatory condition, numerous hormonal and non-hormonal treatments are currently being used off-label in the treatment of this condition, succeeding in controlling, sometimes not fully efficiently, the resulting symptoms.
Among hormonal treatments, progestins have been proposed. Decreased expression of progesterone receptors (PR) A and B has been observed in adenomyotic tissue, similar to endometriosis. Progesterone induces antiproliferative activity through binding to its receptors. The observed reduction in PR expression could partially explain the pathogenesis of adenomyosis and the poor response to progestins.
Although adenomyotic tissue has lower levels of PR, a good response to high-dose topical progesterone has been demonstrated. Although several molecules have been tested, such as levonorgestrel, dienogest, and danazol, to date there are no randomized controlled trials on the use of progestins in the treatment of adenomyosis that would allow clear guidelines on their use in this setting.
Among the progestins commercially available today is drospirenone, which is used clinically as a progestin in oral contraceptives. Drospirenone is a synthetic progestin similar to human progesterone and is a potent inhibitor of mineralocorticoid activity. Drospirenone has been shown to significantly reduce the diameter and maximal volume of ovarian endometrioma, reduce dysmenorrhea, reduce postoperative anatomic and symptomatic recurrence rates, and decrease serum CA125 levels. Drospirenone also acts on the endometrium, reducing its proliferation and thus improving menorrhagia symptoms and has also been shown to reduce Ki-67 expression in the human endometrium when administered orally with and without E2.
Despite reports of these clinical effects on endometriosis, the direct effects of drospirenone on adenomyosis have never been tested.
The aim of study is to evaluate the efficacy and safety of drospirenone in the treatment of adenomyosis, and its impact on improved quality of life and sexual life.
To date, no clear guidelines are available regarding the treatment of adenomyosis, however, resembling endometriosis, as it too is a sex hormone-dependent inflammatory condition, numerous hormonal and non-hormonal treatments are currently being used off-label in the treatment of this condition, succeeding in controlling, sometimes not fully efficiently, the resulting symptoms.
Among hormonal treatments, progestins have been proposed. Decreased expression of progesterone receptors (PR) A and B has been observed in adenomyotic tissue, similar to endometriosis. Progesterone induces antiproliferative activity through binding to its receptors. The observed reduction in PR expression could partially explain the pathogenesis of adenomyosis and the poor response to progestins.
Although adenomyotic tissue has lower levels of PR, a good response to high-dose topical progesterone has been demonstrated. Although several molecules have been tested, such as levonorgestrel, dienogest, and danazol, to date there are no randomized controlled trials on the use of progestins in the treatment of adenomyosis that would allow clear guidelines on their use in this setting.
Among the progestins commercially available today is drospirenone, which is used clinically as a progestin in oral contraceptives. Drospirenone is a synthetic progestin similar to human progesterone and is a potent inhibitor of mineralocorticoid activity. Drospirenone has been shown to significantly reduce the diameter and maximal volume of ovarian endometrioma, reduce dysmenorrhea, reduce postoperative anatomic and symptomatic recurrence rates, and decrease serum CA125 levels. Drospirenone also acts on the endometrium, reducing its proliferation and thus improving menorrhagia symptoms and has also been shown to reduce Ki-67 expression in the human endometrium when administered orally with and without E2.
Despite reports of these clinical effects on endometriosis, the direct effects of drospirenone on adenomyosis have never been tested.
The aim of study is to evaluate the efficacy and safety of drospirenone in the treatment of adenomyosis, and its impact on improved quality of life and sexual life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: