Safety and efficacy of Hemopran protective endorectal cream in the management of pregnancy-related haemorrhoidal disease: a single-center study
| ISRCTN | ISRCTN71491809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71491809 |
| Sponsors | Assisted Medical Reproduction (AMP) Center of Papardo Hospital, Messina, Ekuberg Pharma |
| Funder | Ekuberg Pharma |
- Submission date
- 24/04/2026
- Registration date
- 07/05/2026
- Last edited
- 06/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Haemorrhoidal disease (HD) is a common condition during pregnancy, often associated with discomfort, pain, and reduced quality of life. Treatment options are limited due to safety considerations in pregnant women. This study aimed to evaluate the effectiveness and tolerability of Hemopran® protective endorectal cream, a CE-marked medical device, in reducing the symptoms and signs of grade I–II haemorrhoidal disease in pregnant women.
Who can participate?
Pregnant women aged 18 years and over, in any trimester, with grade I or II haemorrhoidal disease
What does the study involve?
Participants received treatment with Hemopran® protective endorectal cream and were monitored over time. Outcomes were assessed using validated patient-reported outcome measures to evaluate symptom improvement and treatment tolerability.
What are the possible benefits and risks of participating?
Possible benefits include relief of haemorrhoidal symptoms and improved quality of life. Potential risks are minimal and may include local irritation or hypersensitivity reactions to the product components.
Where is the study run from?
Assisted Medical Reproduction (PMA) Center, Papardo Hospital, Messina (Italy)
When is the study starting and how long is it expected to run for?
February 2025 to December 2025
Who is funding the study?
Ekuberg Pharma S.r.l. (Italy)
Who is the main contact?
Dr Davide Carati, davide.carati@ekubergpharma.com
Contact information
Scientific, Principal investigator, Public
Via Firenze
Sternatia
73010
Italy
 ORCID ID |
0000-0003-2360-3456 |
|---|---|
| Phone | +39 (0)3294513080 |
| davide.carati@ekubergpharma.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Basic science, Prevention, Supportive care, Treatment |
| Scientific title | Safety and efficacy of Hemopran protective endorectal cream in the management of pregnancy-related haemorrhoidal disease: a single-center study |
| Study acronym | 02-25 |
| Study objectives | The primary outcome of the study was the reduction in the intensity and frequency of hemorrhoidal symptoms, as assessed by changes in individual Hemorrhoidal Disease Symptom Score (HDSS) items and in the total HDSS score between baseline and the end of treatment. Secondary outcomes included changes in health-related quality of life, evaluated through individual SHS-HD items and the overall SHS-HD score, as well as treatment tolerability and safety. |
| Ethics approval(s) |
Approved 11/02/2025, Local ethics committee of Messina (Via Consolare Valeria, 1, Messina, 98125, Italy; +39 (0)90 2217347; comitato.etico@polime.it), ref: 02-25 |
| Health condition(s) or problem(s) studied | Hemorrhoidal disease grade I–II in pregnant women |
| Intervention | All enrolled patients were treated with Hemopran® protective endorectal cream, a topical endorectal formulation indicated as a coadjuvant treatment for HD and anorectal mucosal irritation. Participants were instructed to apply the cream topically twice daily, preferably after personal hygiene and bowel movements, for a total treatment duration of 14 consecutive days. Treatment adherence and tolerability were assessed during follow-up. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hemopran® protective endorectal cream |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Female |
| Target sample size at registration | 140 |
| Total final enrolment | 140 |
| Key inclusion criteria | 1. Women aged ≥18 years with a confirmed pregnancy in any trimester 2. Clinical diagnosis of non-thrombosed grade I or II hemorrhoidal disease (HD) according to the Goligher classification |
| Key exclusion criteria | 1. Advanced HD requiring surgical intervention (grade III or IV) 2. The presence of concomitant anorectal conditions such as anal fissures or perianal abscesses 3. Known hypersensitivity to any component of the study product 4. The use of topical or systemic anti-hemorrhoidal treatments within 14 days prior to enrollment |
| Date of first enrolment | 11/02/2025 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Italy
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan |
Editorial Notes
06/05/2026: Study's existence confirmed by the local ethics committee of Messina.
