Heavy Menstrual Bleeding Clinical Trial
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | July 30, 2018 |
Est. primary completion date | July 30, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: Women with complaints of abnormal bleeding during use of Mirena independently of the length of use Exclusion Criteria: Delivery in the last six months Breastfeeding Hematological disorder Use of anticoagulants Uterine leiomioma |
Country | Name | City | State |
---|---|---|---|
Brazil | University of Campinas | Campinas | SP |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uterine bleeding control (stop bleeding) | Uterine bleeding control (stop bleeding) among users of Mirena after use of UPA or placebo | Three months | |
Secondary | Endometrial control | Endometrial thickness | Three months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02934789 -
Effectiveness of Truclear on Patient Quality of Life
|
N/A | |
Completed |
NCT02925494 -
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Recruiting |
NCT04959396 -
IUB SEAD RED (Revolutionary Endometrial Ablation Device Study
|
N/A | |
Active, not recruiting |
NCT04778072 -
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
|
N/A | |
Terminated |
NCT05026502 -
A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
|
||
Recruiting |
NCT06064851 -
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients
|
N/A | |
Terminated |
NCT04132349 -
Ulipristal Acetate in Symptomatic Uterine Fibroid
|
Phase 4 | |
Completed |
NCT00386308 -
Efficacy and Safety Study of XP12B in Women With Menorrhagia
|
Phase 3 | |
Completed |
NCT03412890 -
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Active, not recruiting |
NCT04477837 -
Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
|
||
Completed |
NCT05176496 -
A Study Called Champion-HMB to Learn More About Females With Heavy Menstrual Bleeding and Available Treatments to Enable Earlier Diagnosis and to Predict Courses of Treatment
|
||
Completed |
NCT01431326 -
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
|
||
Completed |
NCT00401193 -
Efficacy and Safety of XP12B in Women With Menorrhagia
|
Phase 3 | |
Completed |
NCT03317795 -
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
|
Phase 4 | |
Completed |
NCT02943655 -
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
|
Phase 3 | |
Completed |
NCT03070951 -
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Recruiting |
NCT05685199 -
Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
|
||
Completed |
NCT05406960 -
Therapeutic Effect of Herbal Infusion on Menometrorrhagia
|
N/A | |
Not yet recruiting |
NCT05079815 -
Heavy Menstrual Bleeding and Iron Deficiency Anemia
|
||
Active, not recruiting |
NCT02449304 -
Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device
|
Phase 4 |