---
title: Use of Recombinant Factor VII as a Prophylactic Therapy for Adolescent Females With Heavy Menstrual Bleeding
nct_id: NCT06258980
overall_status: COMPLETED
sponsor: Minia University Hospital
study_type: OBSERVATIONAL
primary_condition: Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06258980.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06258980"
ct_last_update_post_date: 2024-02-14
last_seen_at: "2026-05-12T06:12:31.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Use of Recombinant Factor VII as a Prophylactic Therapy for Adolescent Females With Heavy Menstrual Bleeding

**Official Title:** Professor and Consultant of Pediatric Hematology Faculty of Medicine, Minia University, Al Minya, Egypt.

**NCT ID:** [NCT06258980](https://clinicaltrials.gov/study/NCT06258980)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 3
- **Lead Sponsor:** Minia University Hospital
- **Conditions:** Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention
- **Start Date:** 2023-01-15
- **Completion Date:** 2024-02-05
- **CT.gov Last Update:** 2024-02-14

## Brief Summary

the study is conducted on adolescent females proved to be Glanzmanns Thrombaesthenia with heavy menstrual bleeding by the use of 3 doses of recombinant factor VII in the first day of their cycles. bleeding profile and quality of life were assessed before and 1year after this regular recombinant factor VII administration.

## Eligibility

- **Minimum age:** 12 Years
- **Maximum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* adolescent females proved to be Glanzmanns Thrombaesthenia heavy menstrual bleeding no improvment by platelet transfusion or antifibrinolytic therapy

Exclusion Criteria:

chronic systemic disease previous allergic reaction to recombinant FVII

\-
```

## Arms

- **heavily menstruating females with glanzmannns Thrombaesthenia**

## Interventions

- **Proph7** (DRUG) — Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females

## Primary Outcomes

- **regular accepted menstrual cycles less than 6 days** _(time frame: 1 year)_

## Locations (1)

- Gehan Lotfy Abdel Hakeem, Al Minyā, Egypt

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gehan lotfy abdel hakeem|al minyā||egypt` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06258980.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06258980*  
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