Endometrial PolypPhase 3NCT03309709
Endometrial Polyps Regression With Progesterone Therapy
A Phase 3 study testing subcutaneous progesterone in people with Endometrial Polyp, run by University Magna Graecia at 2 sites in Italy.
Trial summary
This prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Polyp
- What is being tested?
- subcutaneous progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesItaly
- Study dates
- 8 Oct 2017to 30 Dec 2019
- Phase
- Phase 3
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment
- signed informed consent
Who cannot join
- estrogenic and\or progestinic therapy two months before the enrollment
- tamoxifen therapy
- pelvic inflammatory disease
- gynaecologic neoplasia
- previous chemotherapy and radiotherapy
- autoimmune diseases, chronic disease, metabolic, and endocrine (hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease)
Show all 9Show fewer
- menopause
- Hypogonadotropic hypogonadism
- drugs causing menstrual irregularities
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Pugliese Ciaccio
Catanzaro, Calabria, 88100
Roberta Venturella, MD, +390961883234, venturella@unicz.it
Gian Marco Miele, MD, +390961883234, gianmarcomiele@live.com
- Recruiting
Federico II University
Naples, 80121
Gabriele Saccone, MD, 00393394685179
Antonio Raffone, MD
About this study
Official title: Efficacy of Subcutaneous Progesterone in Premenopausal Woman With Endometrial Polyp: a Multicentric Randomized Control Trial
This prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
Read the detailed description
In premenopause, 25% of endometrial polyps regresses spontaneously in 1 year. According to guidelines, given that most premenopausal polyps are not malignant, there is an option for expectant approach with no surgical intervention. Studies on the efficacy of medical treatments for endometrial polyps are also recommended by gynaecologic societies, with the aim of finding cost-saving not invasive strategies to manage this common pathology. Up to now, nobody has investigated the effect of progestin administration on polyps, but molecular and clinical data suggest that the antiestrogenic effect of this hormone can be exploited to increase and speed-up their regression rate. Our preliminary results on the effect of three months of progesterone demonstrated a regression rate of 47,5% in women treated vs 12,5% in those don't receiving treatment.
Accordingly, in this prospective randomized study we aim to compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
- Conditions
- Endometrial Polyp
- Being tested
- subcutaneous progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous progesteroneDrug
Also called Pleyris
25mg daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| watch-and-wait patients | No intervention | patients who receive a watch-and-wait approach |
| Progesterone patients | Experimental | Treatment consists of 7 days of 25 mg subcutaneous progesterone administered from 18° to 25° day of the menstrual cycle and repeated for 3 cycles Receives: Drug: subcutaneous progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyps regression rate
US evidence of normal endometrial line without evidence of polyps
Measured: three months after the starting of treatment or of watch-wait approach
Secondary outcomes (4)
Polyps dimensions
Effect of progesterone on polyps dimensions measured in mm
Measured: three months after the starting of treatment or of watch-wait approach
Correlation between polyps dimension and regression
Correlation between the size of the polyps and the efficacy of progesterone therapy in terms of regression of lesions
Measured: three months after the starting of treatment or of watch-wait approach
Side effects
Evaluation of any side effects
Measured: three months after the starting of treatment
Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score
Effect of progestogen therapy on symptoms possibly present in patients with endometrial polyps, assessed with PBAC (Pictorial blood loss assesment chart) score.
Patients will be asked to fill in the PBAC score during the first menstrual period following diagnosis and during the three months of medical treatment or watch and wait approach. The "8-days PBAC score" is an objective method used to quantify menstrual blood loss; according to this method, each patient records the extent of uterine bleeding during the first 8 days of menstrual cycle, quantizing it in terms of daily change in diapers and number/size of the clots. Each option has a numeric value (1=no bleeding; 2=spotting; 3=1-8 diapers per day; 4=heavy bleeding) and, based on the result obtained, the monthly PBAC score varies from 0 (amenorrhea) to > 500 (heavy bleeding). Menorrhagia occurs when PBAC score is >100 during a menstrual cycle, corresponding to a blood loss greater than 80 ml.
Measured: three months after the starting of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start8 Oct 2017
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial PolypStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Venturella, University Magna Graecia
- Investigators
- Roberta Venturella, MD, Principal investigator, Magna Graecia University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309709
- Sponsor's protocol ID
- Progesterone Polyps
- Status last verified
- Jan 2019
- First submitted
- 9 Oct 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Venturella R, Miele G, Cefali K, Lico D, D'Alessandro P, Arduino B, Di Cello A, Zullo F, Di Carlo C. Subcutaneous Progesterone for Endometrial Polyps in Premenopausal Women: A Preliminary Retrospective Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):143-147. doi: 10.1016/j.jmig.2018.04.023. Epub 2018 May 2.
PubMed 29729409
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Subcutaneous Progesterone in Premenopausal Woman With Endometrial Polyp: a Multicentric Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03309709
- Acronym / sponsor ID
- Progesterone Polyps
- Conditions
- Endometrial Polyp
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 8 Oct 2017 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 13 Oct 2017 (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.
This prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
Detailed description
In premenopause, 25% of endometrial polyps regresses spontaneously in 1 year. According to guidelines, given that most premenopausal polyps are not malignant, there is an option for expectant approach with no surgical intervention. Studies on the efficacy of medical treatments for endometrial polyps are also recommended by gynaecologic societies, with the aim of finding cost-saving not invasive strategies to manage this common pathology. Up to now, nobody has investigated the effect of progestin administration on polyps, but molecular and clinical data suggest that the antiestrogenic effect of this hormone can be exploited to increase and speed-up their regression rate. Our preliminary results on the effect of three months of progesterone demonstrated a regression rate of 47,5% in women treated vs 12,5% in those don't receiving treatment.
Accordingly, in this prospective randomized study we aim to compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| watch-and-wait patients | No intervention | –patients who receive a watch-and-wait approach |
| Progesterone patients | Experimental | Drug: subcutaneous progesteroneTreatment consists of 7 days of 25 mg subcutaneous progesterone administered from 18° to 25° day of the menstrual cycle and repeated for 3 cycles |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment
- signed informed consent
Key exclusion criteria (9 listed)
- estrogenic and\or progestinic therapy two months before the enrollment
- tamoxifen therapy
- pelvic inflammatory disease
- gynaecologic neoplasia
- previous chemotherapy and radiotherapy
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 |
|---|---|---|
| subcutaneous progesteroneAlso: Pleyris25mg daily for 7 days | Drug | Progesterone patients |
Primary outcome
Polyps regression rate
Time frame: three months after the starting of treatment or of watch-wait approach
US evidence of normal endometrial line without evidence of polyps
4 secondary outcomes
Polyps dimensions
Time frame: three months after the starting of treatment or of watch-wait approach
Correlation between polyps dimension and regression
Time frame: three months after the starting of treatment or of watch-wait approach
Side effects
Time frame: three months after the starting of treatment
Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score
Time frame: three months after the starting of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 29729409Venturella R, Miele G, Cefali K, Lico D, D'Alessandro P, Arduino B, Di Cello A, Zullo F, Di Carlo C. Subcutaneous Progesterone for Endometrial Polyps in Premenopausal Women: A Preliminary Retrospective Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):143-147. doi: 10.1016/j.jmig.2018.04.023. Epub 2018 May 2.
- Individual participant dataSharing planned: No
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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.
Roberta Venturella, MD principal investigator
Magna Graecia University of Catanzaro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing subcutaneous progesterone in people with Endometrial Polyp, run by University Magna Graecia at 2 sites 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 2 inclusion and 9 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Roberta Venturella, MD (+390961883234, venturella@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyps regression rate (time frame: three months after the starting of treatment or of watch-wait approach). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309709, which also lists 1 linked publication.
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 15 Jan 2019.