Abnormal Uterine Bleeding
Conditions
Interventions
IUPLA
IUAHC01
Sponsors
Avana Health
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age between 25 and 55 years old, inclusive. 2. Have a history of the symptom of heavy menstrual bleeding presumed to be AUB-E, or AUB-LSM Type 4 tumors – less than 4 cm for a single myoma 3. Will have a history of cyclically predictable onset of menses every 24-38 days with no more than 9 days of variance (shortest to longest) in the past six months. 4. Are scheduled for a hysterectomy, or plans to have a hysterectomy in the next 60 days 5. Screening hemoglobin levels > 7.0 g/dL 6. Uterine ultrasound calculated uterine volume of = 30 mL 7. Negative serum pregnancy test at the Screening visit 8.Sexually active women agree to use an effective method of contraception throughout the course of the study. For this study, effective methods of contraception are considered to be: Barrier method, i.e., (a) condom (male or female) with spermicide or (b) diaphragm with spermicide; Vasectomy (partner); avoidance, if in line with the preferred and usual lifestyle of the subject [defined as refraining from heterosexual intercourse] 9. Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram. 10. Provide voluntary written/thumb-printed informed consent. 11. Be willing to comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits. 12. In otherwise good health as determined by medical history and physical examination. 13. For the duration of the study, be willing to avoid medication not prescribed by the study team. 14. Have a readily identifiable place of residence identified on Google Maps. 15. Can limit travel outside the study area during the post-treatment period of study participation At the end of the Qualification Phase, participants must meet all the following additional inclusion criteria to continue into the Treatment Phase (randomization and treatment): 16. Demonstrated baseline PBAC of >150. 17. Have demonstrable visible active bleeding at the time of treatment
Exclusion criteria
Exclusion criteria: 1. Currently on systemic therapy that alters endogenous gonadal steroid production. These include oral, transdermal, and transvaginal estrogen and progestin-containing contraceptives, oral or injectable progestins including depomedroxyprogesterone acetate (DMPA), and gonadotropin releasing hormone (GnRH) modulators including GnRH agonists and antagonists. 2. Current use of tranexamic acid (eg Lysteda®) 3. Less than 12 months since the last use of DMPA. 4. Less than 6 months since the last use of oral, transdermal or transvaginal hormonal agents, including oral GnRH antagonists. 5. Less than 9 months since the last injection of depot leuprolide acetate (Depolupron®) 11.25 mg (other formulations will depend on the dose). 6. Has a progestin-releasing intrauterine system (IUS) (Mirena® or other), OR less than 6 months since removal of such a device. 7. Underwent prior uterine surgery that interrupts the integrity of the myometrium (e.g., transmural myomectomy, classical Cesarean section, endometrial ablation (by any technique), hysteroscopic myomectomy). 8. Endometrial curettage (D&C) in the last 3 months. 9. Endometrial biopsy in the last 3 months. 10. Presence of bacteremia, sepsis, or other active systemic infection 11. Previous gynecological malignancy including, not limited to vaginal, cervical, endometrial, fallopian tube, and ovarian cancer. This does NOT include cervical intraepithelial neoplasia (CIN), but DOES INCLUDE atypical endometrial hyperplasia, also known as endometrial intraepithelial neoplasia (EIN). 12. Individuals who have known submucous leiomyomas, specifically excluding those with AUB-LSM meaning those with FIGO Types 0, 1, 2. 13. Individuals with AUB-LSM Type 4 tumors – greater than 4 cm for a single myoma 14. Individuals who have known uterine adenomyosis 15. Post-partum = 6-months 16. Breastfeeding in the past six months 17. Currently using anticoagulant treatment 18. Have used any other investigational product within 90 days prior to randomiz
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited AEs Days 0-7 post treatment, Unsolicited outcomes throughout the entire duration of study participation | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug impact on post-treatment PBAC score;Bioavailability of experimental drug on day of drug administration | — |
Countries
Kenya
Contacts
Public ContactMichael Royals
Chief Science Officer
Outcome results
None listed