Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Not authorised
Participants planned
80
Countries
1
Sites
3
Endometriosis in women with involuntary infertility
to evaluate the effectiveness of cabergoline on endometriosis associated pain symptoms among infertile patients with mild or moderate endometriosis.
Key facts
- Sponsor
- Turku University Central Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Decision date (initial)
- 2022-12-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
to evaluate the effectiveness of cabergoline on endometriosis associated pain symptoms among infertile patients with mild or moderate endometriosis.
Secondary objectives 1
- to evaluate the effectiveness of cabergoline on endometriosis associated QoL among infertile patients with mild or moderate endometriosis.
Conditions and MedDRA coding
Endometriosis in women with involuntary infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10014778 | Endometriosis | 100000004872 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Females - Age 20 – 37 year - Mild or moderate endometriosis either diagnosed by surgery or ultrasound or strong clinical suspicion of peritoneal endometriosis based on NICE Guidelines - Endometriosis related pain NRS > 3 (dysmenorrhea) - Primary or secondary infertility for 1 year or more - Cause of infertility: mild or moderate endometriosis, unknown ‘ - Regular ovulatory cycles
Exclusion criteria 1
- - Body mass index more than 35 kg/m2 or less than 18 kg/m2 - Severe endometriosis defined as o > 4 cm unilateral endometrioma or bilateral endometriomas o Adhesions above the level of sacrouterine ligaments demonstrated by absent sliding sign in ultrasound examination or detected surgically o Deep invasive endometriosis of bowel - Hormonal suppression of endometriosis or hormonal contraception within 6 mo - Other diagnosed cause of infertility o Ovulatory dysfunction o Tubal factor (Tubal occlusion, hydrosalpinx, tubal sterilization) o Uterine factor (Submucous myoma, intramural myoma > 4 cm, Uterine malformation apart from Uterus arcuatus) o Male factor o Social infertility - Indication for IVF-treatment - Hyperprolactinemia, macroprolactinemia excluded - Unbalanced hypothyreoidism - Cardiac disorders - Pleural, pericardiac or retroperinoteal fibrosis - Liver dysfunction - Clinical depression or other phychiatric disorder - Previous malignancy - Allergy for cabergoline - Insufficient skills in Finnish, Swedish or English language
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The worst Numeric Rating Scale of menstrual pain, weekly pelvic pain and pain during intercourse at baseline, during the treatment, at the end of treatment and at follow up after three natural or ovulation induction cycles and the change of worst NRS at baseline, at the end of treatment and at follow up after three natural or ovulation induction cycles. The number of subjects with reduction of the worst NRS of menstrual pain, weekly pelvic pain and weekly pain during intercourse by ≥30%, ≥50% ja
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1968444 · Product
- Active substance
- Cabergoline
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 3 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- G02CB03 — CABERGOLINE
- Marketing authorisation
- 11079
- MA holder
- PFIZER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Encapsulated in gelatin cover
Placebo 1
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Central Hospital
- Sponsor organisation
- Turku University Central Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Central Hospital
- Contact name
- Varpu Jokimaa
Public contact point
- Organisation
- Turku University Central Hospital
- Contact name
- Varpu Jokimaa
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Not authorised | 80 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Tampere University Hospital
Department of Obstetrics and Gynecology, Kalevantie 4, 33100, Tampere
Central Finland Hospital District Central Finland Hospital Nova
Department of Obstetrics and Gynecology, Hoitajantie 3, 40620, Jyvaskyla
Oulu University Hospital
Department of Obstetrics and Gynecology, Kajaanintie 50, 90220, Oulu
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-09 | Finland | Not acceptable 2022-12-19
|
2022-12-22 |