Health Condition 1: null- Subjects having uterine bleeding caused by fibroids. Have at least one uterine myoma of â?¥ 3 cm diameter in size and no myoma larger than 10 cm diameter in size diagnosed by ultrasound.
Conditions
Interventions
Intervention1: Ulipristal acetate (5 mg tablets),: 5 mg tablets, to be taken orally, once daily for a period of 12 weeks
Control Intervention1: Leuprolide acetate: 3.75 mg intramuscular injection, to
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: A voluntarily given written, signed & dated informed consent from all female subjects or their legally acceptable representatives and ready to participate in audio video consent. Premenopausal woman between 30 and 50 years (both inclusive). Body mass index (BMI) of 18 to 35. Subjects having uterine bleeding caused by fibroids. Uterine size equivalent to that of a pregnancy of no more than 16 weeks of gestation. Have at least one uterine myoma of >= 3 cm diameter in size and no myoma larger than 10 cm diameter in size diagnosed by ultrasound. Have a clinical breast examination without significant findings at the screening visit. If of childbearing potential the subject must be practicing a non-hormonal method of contraception as listed below: - Sexual abstinence - Diaphragms - Condom or partner with a vasectomy performed at least 6 months prior to the study and confirmed azoospermia.
Exclusion criteria
Exclusion criteria: Has a history of uterus surgery (except caesarean section or cervical conisation), endometrial ablation or uterine artery embolization. Has a history of or current uterine, cervical, ovarian or breast cancer. Has a history of atypical hyperplasia or a current endometrium hyperplasia (atypical or non-atypical) or adenocarcinoma or similar lesions in the screening biopsy or in a biopsy performed within the past 6 months. Has a condition requiring immediate blood transfusion or a level of Hb Has a known hemoglobinopathy (i.e. Sickel Cell anaemia and Thalassamia). Has a known severe coagulation disorder. Has a large uterine polyp ( > 2cm). Has one or more ovarian cysts >= 4cm in diameter diagnosed by Ultrasound. Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist. Has been taking: a. Treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within the month before the screening visit, b. Acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexamic acid: within one week before the screening visit, c. Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months before the screening visit, respectively. Is likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins (systemic or progestin releasing intra-uterine system), oral contraceptives, systemic glucocorticoids (oral and injectable), acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexamic acid. Has a history of or known current osteoporosis. Subjects with clinically significant hepatic or renal impairment which might compromise subject safety as per PI discretion Subjects with genital bleeding of unknown etiology or for reasons other than uterine fibroids Has a positive pregnancy test at screening/randomization visits or is nursing or planning a pregnancy during the course of the study. Has a current (within twelve months) problem with alcohol or drug abuse. Has a current history of severe asthma. Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. Has an abnormal baseline findings, any other medical condition(s) or psychiatric condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subjectâ??s safety or interfere with study evaluations. Has an allergy to GnRH agonist, SPRMs or progestins or any of the ingredients of the study drug tablet. Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to visit 1.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Global pain severity score.Timepoint: to week 4, week 8, and week 12;Change from baseline in uterine volume assessed by ultrasound.Timepoint: to Week 12;Change in bleeding pattern in both the treatment groups (consecutive 28 day PBAC scores). Timepoint: from baseline to week 4, week 8, and week 12 visits;Changes from baseline in the total volume of the three largest myomas (fibroid) assessed by ultrasound Timepoint: to week 12;Investigator global assessment scoreTimepoint: at week 4, week 8, and week 12.;Patient global assessment scoreTimepoint: at week 4, week 8, and week 12;Proportion of subjects with Amenorrhea in both the treatment groups (28 day PBAC score â?¤ 2).Timepoint: at week 4, week 8, and week 12 | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with control of uterine bleeding in both the treatment groups (PBAC score of less than 75 {summed over the preceding 28-day period}Timepoint: week 12 | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Ltd
Outcome results
None listed