Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
120
Countries
3
Sites
10
Endometriosis
To evaluate the efficacy of both (i) AMY109 and (ii) AMY109 and desogestrel compared with (iii) desogestrel in disease severity assessed by laparoscopic appearance in women with endometriosis ((only in the UK) …
Key facts
- Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 21 Oct 2024 → ongoing
- Decision date (initial)
- 2024-05-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Chugai Pharmaceutical Co., Ltd
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Pharmacodynamic, Efficacy, Safety, Pharmacokinetic
To evaluate the efficacy of both (i) AMY109 and (ii) AMY109 and desogestrel compared with (iii) desogestrel in disease severity assessed by laparoscopic appearance in women with endometriosis ((only in the UK) To evaluate the efficacy of both (i) AMY109 and (ii) AMY109 and desogestrel compared with (iii) desogestrel in disease severity assessed by magnetic resonance imaging (MRI)
Conditions and MedDRA coding
Endometriosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10014778 | Endometriosis | 100000004872 |
Regulatory references
- Scientific advice from competent authorities
- Medicines And Healthcare Products Regulatory Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Female patients between 18 and 49 years of age inclusive at the time of written informed consent
- Agree to switch from usual analgesics for dysmenorrhea, dyspareunia, and NMPP to analgesics permitted by the study protocol
- Has moderate to severe endometriosis-associated NMPP (NRS score of ≥4 on ≥ 4 days of the screening period) and dysmenorrhea (NRS score of ≥4 on ≥ 2 days of the screening period)
- The laparoscopy cohort only (only in the UK): Patient who is willing to have laparoscopic surgery after study treatment is completed and understands the surgery may be delayed by participation in the study. • The investigators should confirm the patient is clinically suitable for receiving a surgical treatment for her endometriosis
- The laparoscopy cohort only(only in the UK): Patients who have received a laparoscopic diagnosis within 9 months before entering the screening period but have not received any surgical treatment at the laparoscopic diagnosis (for example due to severity of disease). • This diagnostic laparoscopy should have been conducted outside of the study in line with standard practice • Biopsies taken at laparoscopic diagnosis which are not considered treatments are permitted
- The laparoscopy cohort only(only in the UK): Patient who is staged Ⅲ/Ⅳ endometriosis according to the revised American Society of Reproductive Medicine (r-ASRM) score by central readers based on images obtained at the laparoscopic diagnosis • Videos/operational records or notes can be used to support staging the score if available
- The imaging cohort only(only in the EU): Patient who has clinical diagnosis of endometriosis based on at least one of the following criteria: • Laparoscopy/laparotomy performed within 10 years before written informed consent • Clinical symptoms and imaging assessment (i.e., TVUS or MRI) before entering treatment period. Patient must have at least one ovarian endometrioma on MRI assessed by a central reader during the screening period
- The imaging cohort only(only in the EU): Patient who has at least 1 endometriotic nodule with > 5mm short diameter and > 10 mm long diameter using MRI assessed by a central reader during the screening period • Patients with a nodule indistinct from adenomyosis can be enrolled if another endometriotic nodule or endometrioma is identified during the screening period
Exclusion criteria 5
- Clinically significant abnormalities in laboratory test results, physical examination, vital signs, 12-lead ECG, chest X-ray, hematology (e.g., Hemoglobin [Hb] < 90 g/L), blood chemistry, serology, and urinalysis at screening
- Patient has chronic pelvic pain that is not caused by endometriosis and that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g. pelvic inflammatory disease)
- Patient has a surgical history of hysterectomy and/or bilateral oophorectomy
- Prior treatment with antibody preparations (commercially available or investigational) within 6 months or 5 half-lives of the drug, whichever is longer, before entering the screening period
- Prior treatment with anti-IL-8 antibody preparations
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes of total score and stage in the revised American Society of Reproductive Medicine (r-ASRM) score assessed by laparoscopy from pre-treatment to post-treatment (only in the UK) Change in sum of long (i.e., the largest) diameters of endometriotic nodules assessed by MRI from pre-treatment to post-treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10597369 · Product
- Active substance
- AMY109
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 130 mg/kg milligram(s)/kilogram
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CHUGAI PHARMACEUTICAL CO. LTD
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
SUB07003MIG · Substance
- Active substance
- Desogestrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 µg microgram(s)
- Max total dose
- 27300 µg microgram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation of the tablets, repackaging and labelling operations which will be conducted in accordance with Good Manufacturing Practices (GMP).
Feanolla 75 microgram film-coated tablets
PRD7884497 · Product
- Active substance
- Desogestrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 µg microgram(s)
- Max total dose
- 27300 µg microgram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03AC09 — DESOGESTREL
- Marketing authorisation
- PL35507/0195
- MA holder
- LUPIN HEALTHCARE (UK) LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation of the tablets, repackaging and labelling operations which will be conducted in accordance with Good Manufacturing Practices (GMP).
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 6
SUB08098MIG · Substance
- Active substance
- Ibuprofen
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 2088000 mg milligram(s)
- Max treatment duration
- 29 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB04927MIG · Substance
- Active substance
- Tramadol Hydrochloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 26100 mg milligram(s)
- Max treatment duration
- 29 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03392MIG · Substance
- Active substance
- Naproxen Sodium
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1100 mg milligram(s)
- Max total dose
- 957000 mg milligram(s)
- Max treatment duration
- 29 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13427MIG · Substance
- Active substance
- Codeine Phosphate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 208800 mg milligram(s)
- Max treatment duration
- 29 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09159MIG · Substance
- Active substance
- Naproxen
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 870000 mg milligram(s)
- Max treatment duration
- 29 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 3480000 mg milligram(s)
- Max treatment duration
- 29 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chugai Pharmaceutical Co. Ltd.
- Sponsor organisation
- Chugai Pharmaceutical Co. Ltd.
- Address
- 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Chuo-ku
- City
- Chuo
- Postcode
- 103-8324
- Country
- Japan
Scientific contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Public contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Third parties 16
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Laboratories Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Laboratory analysis |
| Cmic Inc. ORG-100048084
|
Hoffman Estates, United States | Laboratory analysis |
| Rules Based Medicine Inc. ORG-100043610
|
Austin, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 2, Interactive response technologies (IRT), Code 5, Code 8 |
| IQVIA Laboratories LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Riken Genesis Co. Ltd. ORG-100046337
|
Kawasaki, Japan | Laboratory analysis |
| Nordic Bioscience A/S ORG-100009315
|
Herlev, Denmark | Laboratory analysis |
| Specialty Laboratories Inc. ORG-100051017
|
Valencia, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Takara Bio Inc. ORG-100014750
|
Kusatsu, Japan | Laboratory analysis |
| Quest Diagnostics Nichols Institute Inc. ORG-100012789
|
San Juan Capistrano, United States | Laboratory analysis |
| Cmic Pharma Science Co. Ltd. ORG-100040871
|
Nishiwaki, Japan | Laboratory analysis |
| Mediford Corp. ORG-100050000
|
Itabashi-Ku, Japan | Laboratory analysis |
| Micron Inc. ORG-100049152
|
Tokyo, Japan | Laboratory analysis |
| Cerba ORG-100042812
|
Frepillon, France | Laboratory analysis |
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 14 | 1 |
| Poland | Ongoing, recruitment ended | 43 | 7 |
| Romania | Ongoing, recruitment ended | 23 | 2 |
| Rest of world
United Kingdom
|
— | 40 | — |
Investigational sites
Fakultni Nemocnice Brno
Clinic of Gynaecology and Obstetrics, Obilni Trh 526/11, Veveri, Brno-Stred
Hlk Sp. z o.o.
Centrum Medyczne Chodzki HLK, Ul. Witolda Chodzki 17/6, 20-093, Lublin
Clinical Medical Research Sp. z o.o.
n/a, Aleja Wojciecha Korfantego 138, 40-156, Katowice
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
n/a, Al. Wyzwolenia 46/16u, 71-500, Szczecin
Niepubliczny Zaklad Opieki Zdrowotnej Medem Wilk Sp. j.
n/a, Ul. Siemianowicka 5a, 40-301, Katowice
Gyncentrum Sp. z o.o.
NZOZ Gyncentrum, Ul. Zelazna 1, 40-851, Katowice
Gyncentrum Sp. z o.o.
NZOZ Gyncentrum-Oddzial Warszawa, Rondo Organizacji Narodow Zjednoczonych 1, 00-124, Warsaw
Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski sp.k.
n/a, Ul. Parkowa 8/16, 15-224, Bialystok
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 |
|---|---|---|---|---|---|
| Czechia | 2024-12-20 | 2025-03-05 | 2025-07-18 | ||
| Poland | 2024-10-30 | 2024-10-31 | 2025-07-18 | ||
| Romania | 2024-10-21 | 2024-11-05 | 2025-07-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-71325
- Event date
- 2025-02-20
- Submission date
- 2025-02-24
- In response to
- OTHER
- Member states affected
- Czechia, Romania, Poland
- Event description
- The currently approved protocol specifies a contraception period of 5 half-lives after the last administration of AMY109/AMY109-placebo.
Recent investigations suggest an underestimation of the current half-life of AMY109 in humans. Upon careful consideration of potential factors influencing the results, the Sponsor decided to reevaluate the bioanalytical methodology. Therefore, a new pharmacokinetic assay method was developed and has revealed that the plasma half-life of AMY109 is longer than anticipated at the study initiated. - Measures taken
- The study investigators have been informed via a Dear Investigator Letter (DIL) of the following measures to be implemented immediately:
- The contraception period and the prohibition period for egg collection and live vaccination after the last dosing of AMY109/AMY109-placebo have been extended.
- A new visit will be added to assess patient safety.
- The duration of participation in the study will be extended.
New and currently enrolled participants will be verbally informed, and the consent process will be recorded in the source documents.
The benefit-risk profile of AMY109 has not changed and remains positive for the intended therapeutic use and therefore recruitment and treatment will continue.
The sponsor plans to submit an updated protocol, informed consent form, IB and other relevant documents as a substantial modification as soon as possible.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 80 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507289-14_red_san | 9.0 |
| Protocol (for publication) | D1_Protocol clarification letter 2 2023-507289-14_red_san | PCL2 |
| Protocol (for publication) | D4_Patient facing documents memo_san | N/A |
| Protocol (for publication) | D4_Patient facing documents_ NRS_ENG | 1.0.0 |
| Protocol (for publication) | D4_Patient facing documents_ NRS_PL | 1.0.0 |
| Protocol (for publication) | D4_Patient facing documents_ PGI-I_ENG | 1.0.0 |
| Protocol (for publication) | D4_Patient facing documents_NRS_CZ | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_NRS_RO | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_Pain Medication for Endometriosis_CZ | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_Pain Medication for Endometriosis_ENG | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_Pain Medication for Endometriosis_PL | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_Pain Medication for Endometriosis_RO | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_PGI-I_CZ | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_PGI-I_PL | 1.0.0 |
| Protocol (for publication) | D4_Patient facing documents_PGI-I_RO | 2.0.0 |
| Protocol (for publication) | D4_Patient facing documents_Uterine Bleeding_ENG | 1.0.0 |
| Protocol (for publication) | D4_Patient facing documents_Uterine Bleeding_PL | 1.0.0 |
| Protocol (for publication) | D4_Patient facing documents_Uterine Bleeding_RO | 2.0.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_san | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent procedure_CZR_san | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_Patient Appreciation Items_san | V01Global |
| Recruitment arrangements (for publication) | K2_recruitment material Dr-to-Patient Letter_san_red | V04POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Acers Medication Instruction Card_RO_san | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Acers Study_Imaging Cohort_Patient Study Guide_EN_red | V.04 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Acers Study_Imaging Cohort_Patient Study Guide_RO_red | V04ROM(ro) |
| Recruitment arrangements (for publication) | K2_Recruitment material_ACERS_Thank You Card_RO_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Animation Video storyboard_EN_red | V04 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Animation Video storyboard_RO_redacted | V04ROM(ro) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Animation Video storyboard_san_Redacted | V04CZE01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor to patient letter_EN_red | V04 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor to patient letter_RO_red | V04 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor-to-Patient Letter_san_Redacted | V04CZE01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Medication Instruction Card_san | 02CZE01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Appreciation Items_EN_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_EN_red | V04 |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Brochure_redacted | V04POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_RO_red | V04 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_san_Redacted | V04CZE01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient ID card_RO_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_EN_red | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_RO_red | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Poster_san_red | 02 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_san_Redacted | V02CZE(cs) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Guide_san_Redacted | V04CZE(cs) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physicial Referral Brochure_EN_red | V04 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physicial Referral Brochure_RO_red | V04 |
| Recruitment arrangements (for publication) | K2_recruitment material_Physician Referral Brochure_redacted | V04POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Brochure_san_Redacted | V04CZE01 |
| Recruitment arrangements (for publication) | K2_recruitment material_Study Assessments Overview Animation Video storyboard_redacted | V04POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank You Card_san | V01CZE(cs) |
| Subject information and informed consent form (for publication) | 2023-507289-14- for publication placeholder_san | 1.0 |
| Subject information and informed consent form (for publication) | 2023-507289-14-for publication placeholder_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main CCSR ICF_san Redacted | V4.0CZE2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MainCCSR ICF for imaging_san_red | V4.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN ICF Imaging_EN_red | V3.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN ICF Imaging_RO_red | V4.0ROMro1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_RO_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_RO_san | 1.0ROMro2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_ NRS_san | 2.0.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_ Pain Medication for Endometriosis_san | 2.0.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_ PGI-I_san | 2.0.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_ Uterine Bleeding_san | 2.0.0 |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_eCOA Memo | NA |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_GDPR ICF_san_Redacted | CZE(cs)3.0 |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_Optional CCSR ICF_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_Optional Laparoscopy ICF_clean | V4.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Medication Instruction Card_san | 02 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Appreciation Items_san | 01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient ID Card_san | 01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Study Guide Imaging Cohort_san_red | V04POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material Thank You Card_san | 01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Appreciation Items_san | V01 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Memo_san | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Desogestrel | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Desogestrel | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZ 2023-507289-14_red_san | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG 2023-507289-14_red_san | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL 2023-507289-14_red_san | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis RO 2023-507289-14_red_san | 5.0 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | Poland | Acceptable with conditions 2024-05-13
|
2024-05-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-07 | Poland | Acceptable 2024-09-02
|
2024-07-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-16 | Poland | Acceptable 2025-01-20
|
2025-01-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-06 | Poland | Acceptable 2025-04-07
|
2025-04-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-15 | Poland | Acceptable 2025-06-30
|
2025-07-03 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-15 | Poland | Acceptable 2025-06-30
|
2026-01-15 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-06 | Poland | Acceptable 2025-06-30
|
2026-03-06 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-18 | Acceptable | 2026-05-04 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-18 | Acceptable | 2026-05-06 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-19 | Poland | Acceptable | 2026-04-29 |