Heavy Menstrual BleedingPhase 4NCT03186586
Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena
A Phase 4 study testing Ulipristal acetate in people with Heavy Menstrual Bleeding and Abnormal Bleeding, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Objectives: To assess if the administration of ulipristal acetate (UPA) in users of the levonorgestrel-releasing intrauterine system (LNG-IUS) with breakdown bleeding or abnormal bleeding, could be able to inhibit the bleeding and if this effect will be sustainable up to three months after treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding, Abnormal Bleeding
- What is being tested?
- Ulipristal acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 30 Jul 2018
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with complaints of abnormal bleeding during use of Mirena independently of the length of use
Who cannot join
- Delivery in the last six months Breastfeeding Hematological disorder Use of anticoagulants Uterine leiomioma
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Campinas
Campinas, São Paulo, 13083888
Luis Bahamondes, Md, 55 19 32892856 ext. 209, bahamond@caism.unicamp.br
About this study
Official title: Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena, a Randomized Clinical Trial
Objectives: To assess if the administration of ulipristal acetate (UPA) in users of the levonorgestrel-releasing intrauterine system (LNG-IUS) with breakdown bleeding or abnormal bleeding, could be able to inhibit the bleeding and if this effect will be sustainable up to three months after treatment.
Material and methods: A total of 32 women aged between 18-45 years, users of the LNG-IUS with breakdown bleeding, abnormal bleeding or prolonged bleeding (bleeding more than 14 days) or episodes of bleeding with intervals less than 24 days). The study is an experimental, double blind randomized (16 women will receive UPA 5 mg/day/5 days; 16 women will receive placebo/1 time/day/5 day). The women will invited to participated at the Family Planning clinic at the day they consulted with the complaint of bleeding. That day they will allocated at random to UPA or placebo group. They will oriented to fill out a bleeding calendar through 90 days after the pill intake. In addition a ultrasonography scan will be perform before the first day of pill intake and at 90 days after.
Statistical analysis: A a pilot study the sample was estimated in 26 women (13 at each group) based at the estimative of success of 0.95 with UPA and 0.35 with placebo with significance of 0.05 and power of 80%. The sociodemographic characteristics will be analyzed as mean and SD and will compared through Mann-Whitney, Yates χ2 and Fisher exact tests as apropriate. Also, a regression analysis (Poisson analysis) with the dependent significant variables. The established level of significance will be p < 0.05.
Read the detailed description
The LNG-IUS is a contraceptive method with high efficacy, long acting, reversible with contraceptive failure between 0.1 and 0.5/100 women/year. It released 20 mcg/day of LNG with a life span duration of 5 years. LNG is a synthetic progestin, 19-northestosterone, six times more potent than progesterone, with androgenic properties and with binding with sexual hormones, receptors of human steroids, including receptors of glucocorticoids and mineralocorticoids, with minimal capacity of binding with estrogen receptors. At endometrium level it induce antiproliferative effect and strong expression of local markers and endometrial decidualization, including the prolactin receptor and insulin-like growth factor. The mechanism of action includes effect upon cervical mucus which affects the sperm movements through the reproductive tract which affects fertilization. In some women could be ovulation inhibition. One of the main reason for discontinuation is breakdown bleeding, increase bleeding or abnormal bleeding including heavy menstrual bleeding (HMB) and spotting which is common at the first six month of use. Despite the fact that it is the main cause of discontinuation, there is no effective treatment for these cases. An effective treatment could help in the reduction of reduce the rates of discontinuation, improved the cost-effectiveness and quality of life of users.
A selective progesterone receptor modulator (SPRM) is Ulipristal Acetate (UPA) is approved in the European Union as Esmya® as a tretament to reduce the ueterine leiomyomas at te dose of 5 mg/day and it under evaluation at the dose of 5-10 mg as oral contraceptive.
This could be an option of treatment for HMB or abnormal bleeding induced by the LNG-IUS. UPA is agonist/antagonist and binding with progesterone to the receptor level. It has ovarian and endometrial activity, with dose-dependent effect in inhibition of ovulation and maturation of the endometrium. There are restricted evidences, that the administration of UPA induce a quick endometrial atrophy and stop the abnormal bleeding.
- Conditions
- Heavy Menstrual Bleeding, Abnormal Bleeding
- Being tested
- Ulipristal acetate, Placebo
- Keywords
- Heavy Menstrual Bleeding, Levonorgestrel relesing intrauterine system
- Medical subject headings
- Menorrhagia, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal acetateDrug
5mg/day/five days
PlaceboDrug
Placebo one pill a day for 5 days at the bleeding episode
| Study group | Role | What they receive |
|---|---|---|
| Ulipristal acetate 5mg/day/five days | Experimental | Women with abnormal bleeding during use of Mirena will allocate to UPA or placebo Ulipristal acetate at 5mg/day/five days Ulipristal 5mg daily for 5 days at the bleeding episode Receives: Drug: Ulipristal acetate |
| Placebo 1 pill/day/five days | Placebo comparator | Women with abnormal bleeding during use of Mirena will allocate to UPA or placebo Placebo at 1pill/day/five days Placebo one pill a day for 5 days at the bleeding episode Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine bleeding control (stop bleeding)
Uterine bleeding control (stop bleeding) among users of Mirena after use of UPA or placebo
Measured: Three months
Secondary outcomes (1)
Endometrial control
Endometrial thickness
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jul 2018 (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 Heavy Menstrual BleedingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Bahamondes, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186586
- Sponsor's protocol ID
- CEMICAMP
- Status last verified
- May 2018
- First submitted
- 12 Dec 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fava M, Peloggia A, Baccaro LF, Castro S, Carvalho N, Bahamondes L. A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system. Int J Gynaecol Obstet. 2020 Apr;149(1):10-15. doi: 10.1002/ijgo.13068. Epub 2019 Dec 11.
PubMed 31777949
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03186586
- Acronym / sponsor ID
- CEMICAMP
- Conditions
- Heavy Menstrual Bleeding, Abnormal Bleeding
- Keywords
- Heavy Menstrual Bleeding, Levonorgestrel relesing intrauterine system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 14 Jun 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.
Objectives: To assess if the administration of ulipristal acetate (UPA) in users of the levonorgestrel-releasing intrauterine system (LNG-IUS) with breakdown bleeding or abnormal bleeding, could be able to inhibit the bleeding and if this effect will be sustainable up to three months after treatment.
Material and methods: A total of 32 women aged between 18-45 years, users of the LNG-IUS with breakdown bleeding, abnormal bleeding or prolonged bleeding (bleeding more than 14 days) or episodes of bleeding with intervals less than 24 days). The study is an experimental, double blind randomized (16 women will receive UPA 5 mg/day/5 days; 16 women will receive placebo/1 time/day/5 day). The women will invited to participated at the Family Planning clinic at the day they consulted with the complaint of bleeding. That day they will allocated at random to UPA or placebo group. They will oriented to fill out a bleeding calendar through 90 days after the pill intake. In addition a ultrasonography scan will be perform before the first day of pill intake and at 90 days after.
Statistical analysis: A a pilot study the sample was estimated in 26 women (13 at each group) based at the estimative of success of 0.95 with UPA and 0.35 with placebo with significance of 0.05 and power of 80%. The sociodemographic characteristics will be analyzed as mean and SD and will compared through Mann-Whitney, Yates χ2 and Fisher exact tests as apropriate. Also, a regression analysis (Poisson analysis) with the dependent significant variables. The established level of significance will be p < 0.05.
Detailed description
The LNG-IUS is a contraceptive method with high efficacy, long acting, reversible with contraceptive failure between 0.1 and 0.5/100 women/year. It released 20 mcg/day of LNG with a life span duration of 5 years. LNG is a synthetic progestin, 19-northestosterone, six times more potent than progesterone, with androgenic properties and with binding with sexual hormones, receptors of human steroids, including receptors of glucocorticoids and mineralocorticoids, with minimal capacity of binding with estrogen receptors. At endometrium level it induce antiproliferative effect and strong expression of local markers and endometrial decidualization, including the prolactin receptor and insulin-like growth factor. The mechanism of action includes effect upon cervical mucus which affects the sperm movements through the reproductive tract which affects fertilization. In some women could be ovulation inhibition. One of the main reason for discontinuation is breakdown bleeding, increase bleeding or abnormal bleeding including heavy menstrual bleeding (HMB) and spotting which is common at the first six month of use. Despite the fact that it is the main cause of discontinuation, there is no effective treatment for these cases. An effective treatment could help in the reduction of reduce the rates of discontinuation, improved the cost-effectiveness and quality of life of users.
A selective progesterone receptor modulator (SPRM) is Ulipristal Acetate (UPA) is approved in the European Union as Esmya® as a tretament to reduce the ueterine leiomyomas at te dose of 5 mg/day and it under evaluation at the dose of 5-10 mg as oral contraceptive.
This could be an option of treatment for HMB or abnormal bleeding induced by the LNG-IUS. UPA is agonist/antagonist and binding with progesterone to the receptor level. It has ovarian and endometrial activity, with dose-dependent effect in inhibition of ovulation and maturation of the endometrium. There are restricted evidences, that the administration of UPA induce a quick endometrial atrophy and stop the abnormal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulipristal acetate 5mg/day/five days | Experimental | Drug: Ulipristal acetateWomen with abnormal bleeding during use of Mirena will allocate to UPA or placebo Ulipristal acetate at 5mg/day/five days Ulipristal 5mg daily for 5 days at the bleeding episode |
| Placebo 1 pill/day/five days | Placebo comparator | Drug: PlaceboWomen with abnormal bleeding during use of Mirena will allocate to UPA or placebo Placebo at 1pill/day/five days Placebo one pill a day for 5 days at the bleeding episode |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with complaints of abnormal bleeding during use of Mirena independently of the length of use
Key exclusion criteria (1 listed)
- Delivery in the last six months Breastfeeding Hematological disorder Use of anticoagulants Uterine leiomioma
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 |
|---|---|---|
| Ulipristal acetate5mg/day/five days | Drug | Ulipristal acetate 5mg/day/five days |
| PlaceboPlacebo one pill a day for 5 days at the bleeding episode | Drug | Placebo 1 pill/day/five days |
Primary outcome
Uterine bleeding control (stop bleeding)
Time frame: Three months
Uterine bleeding control (stop bleeding) among users of Mirena after use of UPA or placebo
1 secondary outcome
Endometrial control
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 31777949Fava M, Peloggia A, Baccaro LF, Castro S, Carvalho N, Bahamondes L. A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system. Int J Gynaecol Obstet. 2020 Apr;149(1):10-15. doi: 10.1002/ijgo.13068. Epub 2019 Dec 11.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ulipristal acetate in people with Heavy Menstrual Bleeding and Abnormal Bleeding, run by University of Campinas, Brazil at 1 site in Brazil.
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 1 inclusion and 1 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 3 May 2018. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Bahamondes, Md (55 19 32892856 ext. 209, bahamond@caism.unicamp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine bleeding control (stop bleeding) (time frame: Three months). 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 NCT03186586, 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 3 May 2018.