AdenomyosisNCT02556411
Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)
A study testing LNG-IUS 13,5 mg Levonorgestrel and Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg in people with Adenomyosis and Chronic Pelvic Pain, run by University of Cagliari.
Trial summary
Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population. The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis, Chronic Pelvic Pain
- What is being tested?
- LNG-IUS 13,5 mg Levonorgestrel and Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Jun 2022
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women affected by adenomyosis with pelvic pain > 4;
- Negative Pap Smear test
Who cannot join
- Pregnancy or research of pregnancy
- Refusal or inability to sign informed consent
- Severe underlying comorbidities (hepatic, oncological)
- Pelvic inflammatory disease
- Other cervical or uterine pathologies
- Deep venous thromboembolism
- Hormonal therapy contraindications
- Smoke
About this study
Official title: Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P
Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.
The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone
- Conditions
- Adenomyosis, Chronic Pelvic Pain
- Being tested
- LNG-IUS 13,5 mg Levonorgestrel, Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNG-IUS 13,5 mg LevonorgestrelDrug
LNG-IUS
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mgDrug
Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime
| Study group | Role | What they receive |
|---|---|---|
| LNG-IUS | Active comparator | LNG-IUS 13,5 mg di Levonorgestrel Receives: Drug: LNG-IUS 13,5 mg Levonorgestrel |
| combined oral contraceptive plus LNG-IUS | Experimental | Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel Receives: Drug: LNG-IUS 13,5 mg Levonorgestrel; Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pelvic pain as measured by visual analogue scale
Measured: Change from baseline pelvic pain at 45 days of treatment
Secondary outcomes (4)
Change of Pelvic pain as measured by visual analogue scale
Measured: Change from baseline pelvic pain at 90 days of treatment
Change of Pelvic pain as measured by visual analogue scale
Measured: Change from baseline pelvic pain at 180 days of treatment
Change of Pelvic pain as measured by visual analogue scale
Measured: Change from baseline pelvic pain at 365 days of treatment
Quality of sexual life
Measured: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of adenomyosis up to 4weeks; Change from baseline were evaluated 45 days after begin of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556411
- Sponsor's protocol ID
- ADENOMYOSIS
- Status last verified
- Feb 2021
- First submitted
- 20 Sep 2015
- Last updated
- 4 Feb 2021
- 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 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P
- ClinicalTrials.gov ID
- NCT02556411
- Acronym / sponsor ID
- ADENOMYOSIS
- Conditions
- Adenomyosis, Chronic Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- 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 characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.
The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNG-IUS | Active comparator | Drug: LNG-IUS 13,5 mg LevonorgestrelLNG-IUS 13,5 mg di Levonorgestrel |
| combined oral contraceptive plus LNG-IUS | Experimental | Drug: LNG-IUS 13,5 mg Levonorgestrel, Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mgLevonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women affected by adenomyosis with pelvic pain > 4;
- Negative Pap Smear test
Key exclusion criteria (8 listed)
- Pregnancy or research of pregnancy
- Refusal or inability to sign informed consent
- Severe underlying comorbidities (hepatic, oncological)
- Pelvic inflammatory disease
- Other cervical or uterine pathologies
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 |
|---|---|---|
| LNG-IUS 13,5 mg LevonorgestrelLNG-IUS | Drug | LNG-IUS, combined oral contraceptive plus LNG-IUS |
| Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mgLevonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime | Drug | combined oral contraceptive plus LNG-IUS |
Primary outcome
Change of Pelvic pain as measured by visual analogue scale
Time frame: Change from baseline pelvic pain at 45 days of treatment
4 secondary outcomes
Change of Pelvic pain as measured by visual analogue scale
Time frame: Change from baseline pelvic pain at 90 days of treatment
Change of Pelvic pain as measured by visual analogue scale
Time frame: Change from baseline pelvic pain at 180 days of treatment
Change of Pelvic pain as measured by visual analogue scale
Time frame: Change from baseline pelvic pain at 365 days of treatment
Quality of sexual life
Time frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of adenomyosis up to 4weeks; Change from baseline were evaluated 45 days after begin of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LNG-IUS 13,5 mg Levonorgestrel and Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg in people with Adenomyosis and Chronic Pelvic Pain, run by University of Cagliari.
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 8 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pelvic pain as measured by visual analogue scale (time frame: Change from baseline pelvic pain at 45 days of treatment). 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 4 Feb 2021.