Uterine LeiomyomaPhase 4NCT01738724
Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin
A Phase 4 study testing Dienogest, Goserelin and Desogestrel in people with Uterine Leiomyoma, run by University of Sao Paulo.
Trial summary
The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Uterine Leiomyoma
- What is being tested?
- Dienogest, Goserelin and Desogestrel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2017
- Phase
- Phase 4
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with 35 - 55 years of age
- Uterine volume between 50cc and 500cc
- Abnormal uterine bleeding probably associated to intramural uterine leiomyomas
Who cannot join
- Pregnancy
- Liver or kidney dysfunction
- Women with only submucosal or subserosal uterine leiomyomas
- Women with contraindications to any of the drugs (categories 3 and 4 of WHO eligibility criteria)
- Use of anticoagulants
- Others causes of abnormal uterine bleeding (endometrial pathology, cervical pathology)
About this study
Official title: Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin
The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use.
Read the detailed description
Uterine leiomyoma is a very prevalent condition among women and, although it is mainly asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine bleeding and pelvic pain or pressure. The standard treatment is surgical (hysterectomy or myomectomy), but there has been continued interest on medical treatments. Progestagens have long been used to control bleeding associated to leiomyomas, but they have not been able to decrease myoma volume. GnRH analogs are well stablished agents, capable of controlling symptoms and decreasing the tumors´volume, but their use is limited by bone loss and menopausal symptoms. A newly introduced progestagen, dienogest, has been studied to treat endometriosis, but its effects on leiomyoma are only starting to be assessed. The investigators are aiming to compare dienogest with the GnRH analog goserelin and the progestagen desogestrel in a randomized trial to see how this new treatment compares with previously used drugs and whether it is similar, inferior or superior to them on controlling leiomyoma associated symptoms and decreasing leiomyoma volume.
- Conditions
- Uterine Leiomyoma
- Being tested
- Dienogest, Goserelin, Desogestrel
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
Also called Allurene, Visanne
Dienogest 2mg pills daily during 6 months
GoserelinDrug
Also called Zoladex
Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
DesogestrelDrug
Also called Cerazette
Desogestrel 75mcg pills daily during six months
| Study group | Role | What they receive |
|---|---|---|
| Dienogest | Experimental | Dienogest 2mg pills daily during 6 months Receives: Drug: Dienogest |
| Goserelin | Experimental | Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months Receives: Drug: Goserelin |
| Desogestrel | Active comparator | Desogestrel 75mcg pills daily during six months Receives: Drug: Desogestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leiomyoma Volume
Measured: After 6 months of medical therapy
Secondary outcomes (2)
Pictorial Blood Assessment Chart (PBAC) Score Reduction
Measured: After 6 months of medical therapy
Number of episodes of vaginal bleeding
Measured: After 6 months of medical therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2016
- Study completionDec 2017
Why it stopped: PI went for a post-doc course and when he came back he moved for another job
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo
- Investigators
- Luiz Gustavo O Brito, MD, PhD, Study chair, FMRP-USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738724
- Sponsor's protocol ID
- FMRPUSP-UROGIN-002
- Status last verified
- Aug 2020
- First submitted
- 23 Nov 2012
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin
- ClinicalTrials.gov ID
- NCT01738724
- Acronym / sponsor ID
- FMRPUSP-UROGIN-002
- Conditions
- Uterine Leiomyoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI went for a post-doc course and when he came back he moved for another job
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Nov 2012 (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.
The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use.
Detailed description
Uterine leiomyoma is a very prevalent condition among women and, although it is mainly asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine bleeding and pelvic pain or pressure. The standard treatment is surgical (hysterectomy or myomectomy), but there has been continued interest on medical treatments. Progestagens have long been used to control bleeding associated to leiomyomas, but they have not been able to decrease myoma volume. GnRH analogs are well stablished agents, capable of controlling symptoms and decreasing the tumors´volume, but their use is limited by bone loss and menopausal symptoms. A newly introduced progestagen, dienogest, has been studied to treat endometriosis, but its effects on leiomyoma are only starting to be assessed. The investigators are aiming to compare dienogest with the GnRH analog goserelin and the progestagen desogestrel in a randomized trial to see how this new treatment compares with previously used drugs and whether it is similar, inferior or superior to them on controlling leiomyoma associated symptoms and decreasing leiomyoma volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dienogest | Experimental | Drug: DienogestDienogest 2mg pills daily during 6 months |
| Goserelin | Experimental | Drug: GoserelinGoserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months |
| Desogestrel | Active comparator | Drug: DesogestrelDesogestrel 75mcg pills daily during six months |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with 35 - 55 years of age
- Uterine volume between 50cc and 500cc
- Abnormal uterine bleeding probably associated to intramural uterine leiomyomas
Key exclusion criteria (6 listed)
- Pregnancy
- Liver or kidney dysfunction
- Women with only submucosal or subserosal uterine leiomyomas
- Women with contraindications to any of the drugs (categories 3 and 4 of WHO eligibility criteria)
- Use of anticoagulants
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 |
|---|---|---|
| DienogestAlso: Allurene, VisanneDienogest 2mg pills daily during 6 months | Drug | Dienogest |
| GoserelinAlso: ZoladexGoserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months | Drug | Goserelin |
| DesogestrelAlso: CerazetteDesogestrel 75mcg pills daily during six months | Drug | Desogestrel |
Primary outcome
Leiomyoma Volume
Time frame: After 6 months of medical therapy
2 secondary outcomes
Pictorial Blood Assessment Chart (PBAC) Score Reduction
Time frame: After 6 months of medical therapy
Number of episodes of vaginal bleeding
Time frame: After 6 months of medical therapy
Results and safety
The study was stopped early (reason given: PI went for a post-doc course and when he came back he moved for another job). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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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.
Luiz Gustavo O Brito, MD, PhD study chair
FMRP-USP
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dienogest, Goserelin and Desogestrel in people with Uterine Leiomyoma, run by University of Sao Paulo.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Aug 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI went for a post-doc course and when he came back he moved for another job). 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?
Leiomyoma Volume (time frame: After 6 months of medical therapy). 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 13 Aug 2020.