PACTR202310719625892

Treatment of abnormal uterine bleeding

A phase 1, single-center, double-blind, randomized, placebo-controlled trial to assess the safety, tolerability and initial efficacy of AHC01 delivered via transcervical catheter in adult females (25-55 years), experiencing abnormal uterine bleeding and scheduled for a hysterectomy.
Avana Health·Phase 1·Pan Africa Clinical Trials Registry·drugNot yet recruiting
Study focus
Disease/Condition
Obstetrics and Gynecology
Intervention type
drug
Sponsor & location
Primary sponsor
Avana Health
Location
Kenya
Timeline & enrollment
Phase
Phase 1
Start date
Jan 01, 1900
End date
Jan 01, 1900
Summary

The treatment of abnormal uterine bleeding (“AUB”), and postpartum hemorrhage (“PPH”), are two of the most dramatic areas of critical unmet need in women’s health. AUB is a broad term that describes irregularities involving frequency, regularity, duration, and volume of uterine blood loss outside of pregnancy. Up to one third of women will experience AUB in their life, with irregularities most commonly occurring at the start ofmenstruation and perimenopause. PPH is a leading cause of maternal mortality. Despite the remarkable prevalence of AUB and PPH, serious gaps in care persist for both. There are no US-FDA approved drugs for the acute management of AUB, and surgical management severely impacts fertility. For women experiencing PPH, the condition is life threatening.Avana’s treatment is designed to directly address blood loss via the exposed or damaged blood vessels, take effect much faster than existing treatments, and provide benefit for longer than other single dose therapeutics without the negative impact to fertility that comes with surgical options (e.g., hysterectomy). This trial seeks to develop additional safety and bioavailability data from women actively experiencing blood loss.

ICD-10 classifications
Obstetric and gynaecological devices associated with adverse incidentsObstructed labour due to other maternal pelvic abnormalitiesObstetric and gynaecological devices associated with adverse incidents : miscellaneous devices, not elsewhere classifiedObstetric and gynaecological devices associated with adverse incidents : diagnostic and monitoring devicesOther complications of obstetric surgery and procedures
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR202310719625892
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for PACTR202310719625892 through Pure Global AI's free database. This Phase 1 trial is sponsored by Avana Health and is currently Not yet recruiting. The study focuses on Obstetrics and Gynecology.

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