AdenomyosisNCT06174792
Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis
An observational study of Adenomyosis, run by University of Palermo at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Drospirenone 4 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 Dec 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Adult
Study population: Women affected by adenomyosis
Who may be able to join
- age 18 years or older;
- regular menstrual cycle;
- adenomyosis diagnosed by imaging analysis (magnetic resonance imaging [MRI] or transvaginal ultrasound);
- no other treatment for adenomyosis for at least 3 months before drospirenone administration;
- painful symptoms (lower abdominal and/or lower back pain) with a score of three points or more on the verbal pain rating scale developed by Harada et al. during the menstrual cycle.
Who cannot join
- endometriosis or uterine leiomyoma diagnosed by imaging analysis (MRI or transvaginal ultrasound);
- benign ovarian cyst including endometrioma;
- other endocrine diseases;
- severe anemia (hemoglobin concentrations <8.0 g/dL).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Andrea Etrusco
Palermo, 90123
Andrea Etrusco, M.D., etruscoandrea@gmail.com
Andrea Etrusco, M.D.
About this study
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.
Read more
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
- Being tested
- Drospirenone 4 MG
- Keywords
- Adenomyosis, Drospirenone, progestin
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone 4 MGDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the level of chronic pain assessed with Visual Analogue Scale
reduction of the level of chronic pain associated with adenomyosis
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start30 Dec 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174792
- Sponsor's protocol ID
- DROS_Adenomyosis
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis
- ClinicalTrials.gov ID
- NCT06174792
- Acronym / sponsor ID
- DROS_Adenomyosis
- Conditions
- Adenomyosis
- Keywords
- Adenomyosis, Drospirenone, progestin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women affected by adenomyosis
Key inclusion criteria (5 listed)
- age 18 years or older;
- regular menstrual cycle;
- adenomyosis diagnosed by imaging analysis (magnetic resonance imaging [MRI] or transvaginal ultrasound);
- no other treatment for adenomyosis for at least 3 months before drospirenone administration;
- painful symptoms (lower abdominal and/or lower back pain) with a score of three points or more on the verbal pain rating scale developed by Harada et al. during the menstrual cycle.
Key exclusion criteria (4 listed)
- endometriosis or uterine leiomyoma diagnosed by imaging analysis (MRI or transvaginal ultrasound);
- benign ovarian cyst including endometrioma;
- other endocrine diseases;
- severe anemia (hemoglobin concentrations <8.0 g/dL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drospirenone 4 MGPatients 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. | Drug | – |
Primary outcome
reduction of the level of chronic pain assessed with Visual Analogue Scale
Time frame: 20 weeks
reduction of the level of chronic pain associated with adenomyosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Etrusco, M.D. (+39 3381614144, etruscoandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of the level of chronic pain assessed with Visual Analogue Scale (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.