Role of an hormonal vaginal therapy, the prasterone pessary, in the improvement of the vaginal/vulvar/urinary symptoms in menopausal women with previous breast cancer or currently under anti-hormonal treatment specific for breast cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Istituto Europeo Di Oncologia S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08], Diseases [C] - Hormonal diseases [C19], Health Care [N] - Health Care Quality, Access, and Evaluation [N05], Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

9 Jan 2025 → ongoing

Decision date (initial)

2024-07-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Theramex Italia (supply prasterone) · Fondazione Umberto Veronesi

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

Establish the subjective improvement of genitourinary symptoms in breast cancer women at intervals defined by the study

Secondary objectives 3

1. To define the role of genito-urinary syndrome on quality of life, in particular on sexual function and mood wellbeing, in women with breast cancer before, during and after the treatment
2. Establish an improvement in tissue trophism throught gynecological evaluation, use of validated scales (Vaginal Health Index) and determination of the maturation index on vaginal cytology
3. Measurement of serum estradiol at set intervals before, during and after treatment

Conditions and MedDRA coding

Postmenopausal women with previous breast cancer or currently under anti-oesterogenic therapy (aromatase inhibitor +/- LHRH analogue) presenting vulvar, vaginal or urinary bothersome symptoms (genitourinary syndrome).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Histologically confirmed breast cancer, completely excised, TNM I-III
2. ER negative or Positive Hormone Receptors Breast Cancer in therapy with aromatase inhibitor +/- LHRHa
3. No evidence of distant metastasis (excluded TNM IV stage)
4. Natural, surgically or treatment-induced menopause according to guidelines definition of menopause
5. Self-identified moderate to severe symptoms of genitourinary syndrome that adversely affect quality of life and VHI (vaginal health index) score <15
6. Clinical signs of vulvovaginal atrophy at the gynaecological examination
7. Normal kidney and liver function
8. Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrolment
9. Women who have or want to have sexual intercourses
10. Written Informed Consent signed and dated by patient

Exclusion criteria 11

1. Vaginal or uterine bleeding of unknown origin
2. Clinically significant metabolic or endocrine disease not controlled by medication
3. Current diagnosis of any non-breast malignancy
4. Metastatic disease
5. Currently on chemiotherapy
6. Currently on treatment with tamoxifen
7. Mentally incompetent or evidence of active substance or alcohol abuse
8. Endometrial hyperplasia
9. Pregnancy or lactation
10. Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit
11. Women with endometriosis, uncontrolled hypertension, vaginal infection and 1st degree heredity for breast cancer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Establish the subjective improvement of genitourinary symptoms in breast cancer women at intervals defined by the study

Secondary endpoints 3

1. To define the role of genito-urinary syndrome on quality of life, in particular on sexual function and mood wellbeing, in women with breast cancer before, during and after the treatment
2. Establish an improvement in tissue trophism throught gynecological evaluation, use of validated scales (Vaginal Health Index) and determination of the maturation index on vaginal cytology
3. Measurement of serum estradiol at set intervals before, during and after treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Istituto Europeo Di Oncologia S.r.l.

Sponsor organisation

Istituto Europeo Di Oncologia S.r.l.

Address

Via Giuseppe Ripamonti 435

City

Milan

Postcode

20141

Country

Italy

Scientific contact point

Organisation

European Institute Of Oncology S.r.l.

Contact name

Silvia Martella

Public contact point

Organisation

European Institute Of Oncology S.r.l.

Contact name

Silvia Martella

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications