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Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis

NCT06174792 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

  • Adenomyosis

Interventions

DRUG

Drospirenone 4 MG

Patients who met all inclusion criteria and had no exclusion criteria would receive one tablet of Drospirenone 4mg daily for 20 weeks, starting from day 2 to day 5 of their menstrual cycle.

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-30
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174792 on ClinicalTrials.gov