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Treatment of abnormal uterine bleeding - Trial PACTR202310719625892

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PACTR202310719625892
Phase 1
Not yet recruiting
drug
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202310719625892
Pure Global
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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.

Study Focus

Obstetrics and Gynecology

drug

Sponsor & Location

Avana Health

Kenya

Timeline & Enrollment

Phase 1

Jan 01, 1900

Jan 01, 1900

Summary

The treatment of abnormal uterine bleeding (โ€œAUBโ€), and postpartum hemorrhage (โ€œPPHโ€), are two of the most dramatic areas of critical unmet need in womenโ€™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.Avanaโ€™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 incidents
Obstructed labour due to other maternal pelvic abnormalities
Obstetric and gynaecological devices associated with adverse incidents : miscellaneous devices, not elsewhere classified
Obstetric and gynaecological devices associated with adverse incidents : diagnostic and monitoring devices
Other complications of obstetric surgery and procedures

Data Source

Pan Africa Clinical Trials Registry

PACTR202310719625892

Non-Device Trial