Uterine Fibroids Study

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

TX155352
  • Ages 18-50
  • Female

Study Summary

To determine the benefit of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids

Eligibility Criteria

Inclusion

Inclusion criteria 

  1.        Premenopausal female aged 18 to 50 years old

  2.        Heavy menstrual bleeding associated with uterine fibroids

  3.        Negative urine pregnancy test

  4.        Adequate endometrial (aspiration) biopsy

  5.        ≥ 39 years of age must have a normal mammogram during screening period or 3 months prior

Exclusion

Exclusion criteria**

  1.       Uterine or cervical polyps that could cause heavy menstrual bleeding

  2.       Unexplained vaginal bleeding

  3.       Undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids 6 months prior

  4.       History of osteoporosis, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic pain

  5.       History of bisphosphonates, calcitonin/calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss

  6.       Gastrointestinal disorder

  7.       History of breast cancer, estrogen-dependent neoplasia, or arterial thromboembolic disease (stroke)

  8.       Protein C, protein S, or antithrombin deficiency/other thrombophilia disorders (Factor V Leiden)

  9.     Jaundice or liver disease

  10.     High grade cervical neoplasia, atypical glandular cells, atypical endocervical cells, or atypical squamous cells favoring high grade

  11.     Cardiovascular disease (angina, congestive heart failure, ventricular arrhythmias, uncontrolled hypertension)

  12.     Participated in an investigational drug or study 1 month prior

  13.     History of thyroid dysfunction or palpable thyroid abnormality

  14.     History of malignancy within 5 years

  15.     History of major depression or other major psychiatric disorder (bipolar, schizophrenia or PTSD)

  16.     Currently pregnant/lactating or intends to become pregnant during the study

  17.     History of illicit drug use or alcohol abuse within 1 year

  18.     Participated in previous clinical study that included the use of relugolix

Study Design

Study Start date:
Estimated Completion Date:

Study Description

For more information please call (504) 455-1310 or (985) 900-2400. We have offices located in Metairie and Covington.