Overview
Sponsor-declared trial summary
Female Infertility
To compare the endometrial function (endometrial gene expression) according to the use of different types of exogenous progesterone available on the market depending on their doses and route of administration (vaginal, subcutaneous or intramuscular).
Key facts
- Sponsor
- Ivi Valencia S.L., Ivi Valencia S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 10 Oct 2021 → 31 Mar 2025
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515811-22-00
- EudraCT number
- 2019-004442-16
- ClinicalTrials.gov
- NCT04499131
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To compare the endometrial function (endometrial gene expression)
according to the use of different types of exogenous progesterone
available on the market depending on their doses and route of
administration (vaginal, subcutaneous or intramuscular).
Conditions and MedDRA coding
Female Infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All women with no history of infertility who agree to participate in the study: 1. Informed consent form (ICF) dated and signed. 2. Age: 18-35 years old , both inclusive 3. Regular menstrual cycles (between 22 and 35 days) 4. In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study
Exclusion criteria 1
- Subjects who meet one or more of the following will not be considered eligible to participate in the pilot study: 1.Simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study. 2.Taking contraceptives in the three months prior to signing informed consent. 3.Presence of uterine pathology (submucosal or intramural myomas >4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx). 4.Background of thrombosis, breast cancer, systemic diseases. 5.Those unable to comprehend the investigational nature of the proposed study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- - Gene expression for the whole transcriptome (22000 genes) related to progesterone treatments response in the window of implantation. - Number of differential expressed genes between P treatment groups in comparison with its natural cycle
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRONTOGEST 100 mg/ml soluzione iniettabile
PRD413494 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 50 mg/ml milligram(s)/millilitre
- Max total dose
- 300 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 005239076
- MA holder
- IBSA FARMACEUTICI ITALIA
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Seidigestan 200 mg cápsulas blandas
PRD308331 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- VAGINAL USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 4800 mg milligram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 64.899
- MA holder
- SEID, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prolutex 25 mg solución inyectable en jeringa precargada.
PRD10910240 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 89065
- MA holder
- IBSA FARMACEUTICI ITALIA
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ivi Valencia S.L.
- Sponsor organisation
- Ivi Valencia S.L.
- Address
- Placa Policia Local 3
- City
- Valencia
- Postcode
- 46015
- Country
- Spain
Scientific contact point
- Organisation
- Ivi Valencia S.L.
- Contact name
- Elena Labarta
Public contact point
- Organisation
- Ivi Valencia S.L.
- Contact name
- Elena Labarta
Ivi Valencia S.L.
- Sponsor organisation
- Ivi Valencia S.L.
- Address
- Placa Policia Local 3
- City
- Valencia
- Postcode
- 46015
- Country
- Spain
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 108 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2021-10-10 | 2025-03-31 | 2021-11-09 | 2025-02-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 1901-VLC-014-EL_Clinical_Trial_sc_FINAL | 3.0 |
| Recruitment arrangements (for publication) | 1901-VLC-014-EL_documento en blanco | 1 |
| Subject information and informed consent form (for publication) | 1901-VLC-014-EL_CI_DEF | 1 |
| Subject information and informed consent form (for publication) | 1901-VLC-014-EL_HIP_sc_DEF | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | prolutex_Nov 2023_VIGENTE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | spc_Prontogest_IT_solution_Excipients__en_VIGENTE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | utrogestan_nov 2023 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-26 | Spain | Acceptable with conditions 2024-07-22
|
2024-07-22 |