Clinical trial • Endocrinology|Other
LETROZOLE for Polycystic ovary syndrome
Clinical trial of LETROZOLE for Polycystic ovary syndrome.
Overview
- Trial Therapeutic Area
- Endocrinology|Other
- Trial Disease
- Polycystic ovary syndrome
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 10-03-2025
- First CTIS Authorization Date
- 30-05-2025
Trial design
Randomised, comparator: human menopausal gonadotrophins (solution for injection, subcutaneous) and follitropin alfa (solution for injection in pre-filled pen, subcutaneous). product metadata lists max daily dose up to 225 (doseuom: mg or iu) and max total amounts over treatment period (maxtotaldoseamount 3150 over maxtreatmentperiod 14 days) as provided in product entries.-controlled trial across 30 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Comparator: HUMAN MENOPAUSAL GONADOTROPHINS (solution for injection, subcutaneous) and FOLLITROPIN ALFA (solution for injection in pre-filled pen, subcutaneous). Product metadata lists max daily dose up to 225 (doseUom: mg or IU) and max total amounts over treatment period (maxTotalDoseAmount 3150 over maxTreatmentPeriod 14 days) as provided in product entries.
- Target Sample Size
- 816
- Trial Duration For Participant
- 240
Eligibility
Recruits 816 Vulnerable populations were not selected for this trial. Participants are adult women aged 18-42 years; 'Inability to give informed consent' is listed as an exclusion. Consent must be provided by the participant; no assent procedures for minors are applicable..
- Pregnancy Exclusion
- Additional contra-indications reported in the SPC are: Hypersensitivity to the active substance, during pregnancy and breast feeding
- Vulnerable Population
- Vulnerable populations were not selected for this trial. Participants are adult women aged 18-42 years; 'Inability to give informed consent' is listed as an exclusion. Consent must be provided by the participant; no assent procedures for minors are applicable.
Inclusion criteria
- {"criterion_text":"- Couples or single women with childwish"}
- {"criterion_text":"- Diagnosed PCOS (normogonadotropic anovulation with hyperandrogenaemia (diagnosed clinically by the presence of excessive acne, androgenic alopecia, or hirsutism or by elevated serum levels of total, bioavailable, or free testosterone or dehydroepiandrosterone sulfate) or polycystic ovaries on ultrasound)"}
- {"criterion_text":"- Age 18-42 years"}
- {"criterion_text":"- Ovulatory for six cycles on letrozole treatment"}
Exclusion criteria
- {"criterion_text":"- Contra-indication to letrozole"}
- {"criterion_text":"- Total motile sperm count (VCM) < 3 million"}
- {"criterion_text":"- Known bilateral fallopian tube pathology or occlusion (patients with at least one patent fallopian tube are eligible)"}
- {"criterion_text":"- Major medical morbidity (e.g. poorly controlled Type I or Type II diabetes, known liver disease or dysfunction based on serum liver enzyme testing, renal disease or abnormal serum renal function)"}
- {"criterion_text":"- Inability to give informed consent"}
- {"criterion_text":"- Additional contra-indications reported in the SPC are: Hypersensitivity to the active substance, during pregnancy and breast feeding"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Pregnancy within 8 months after randomization, leading to a live birth","definition_or_measurement_approach":"Pregnancy occurring within 8 months after randomization that results in a live birth (timeframe and outcome-based endpoint as stated)."}
Secondary endpoints
- {"endpoint_text":"- Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 8 months after randomisation","definition_or_measurement_approach":"Rates of clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage measured within 8 months after randomisation."}
- {"endpoint_text":"- For each participant, the number of treatment cycles initiated, completed and cancelled are evaluated within 8 months after randomisation","definition_or_measurement_approach":"Count of treatment cycles initiated, completed and cancelled per participant within 8 months after randomisation."}
- {"endpoint_text":"- Of all achieved (ongoing) pregnancies occurring within 8 months after randomization (including spontaneous pregnancies) the following outcomes are assessed; multiple pregnancy rate, time to pregnancy, pregnancy complications, perinatal outcomes, type of delivery and outcomes","definition_or_measurement_approach":"Assessment of pregnancy outcomes for pregnancies within 8 months after randomization, including multiple pregnancy rate, time to pregnancy, complications, perinatal outcomes, delivery type and neonatal outcomes."}
- {"endpoint_text":"- Side effects, compliance and smoking behavior during treatment assessed through telephone appointment and questionnaires sent out at 3 months and 8 months after randomisation.","definition_or_measurement_approach":"Safety and behaviour data collected via telephone appointments and questionnaires at 3 and 8 months after randomisation."}
- {"endpoint_text":"- Quality of life and mental health assessed at time of randomization, and at 3 months and 8 months after randomization, using the PCOS-QoL questionnaire and the HADS questionnaire","definition_or_measurement_approach":"PCOS-QoL and HADS questionnaires administered at baseline (randomization), 3 months and 8 months to measure QoL and mental health."}
- {"endpoint_text":"- Budget impact and cost-effectiveness analyses using live birth rates","definition_or_measurement_approach":"Economic analyses (budget impact and cost-effectiveness) using live birth rates as effectiveness measure."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 816
- Recruitment Window Months
- 60
- Consent Approach
- Informed consent obtained from the participant (adult women 18-42). 'Inability to give informed consent' is an exclusion. A subject information sheet and informed consent form are provided (document L1_SIS and ICF); documents and trial materials have translations (protocol synopsis available in EN and NL), indicating availability in Dutch and English.
Methods
- Website texts and online materials (K2_ NL_Recruitment material_Text for websites) targeting women with PCOS and childwish (Netherlands).
- Poster materials (K2_ NL_Recruitment material_Poster) targeting clinic patients and visitors (Netherlands).
- Animation video and script (K2_Recruitment material_Script animatievideo / NL animation) for online dissemination (Netherlands).
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 816
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-05-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 356
- Number Of Sites
- 30
- Number Of Participants
- 816
Sites
- Site Name
- Diakonessenhuis Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- K.L. Deurloo
- Principal Investigator Email
- wetenschapsbureau@diakhuis.n
- Contact Person Name
- K.L. Deurloo
- Contact Person Email
- wetenschapsbureau@diakhuis.n
- Site Name
- Groene Hart Ziekenhuis
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- C.A.H. Janssen
- Principal Investigator Email
- ineke.janssen@ghz.nl
- Contact Person Name
- C.A.H. Janssen
- Contact Person Email
- ineke.janssen@ghz.nl
- Site Name
- Fertiliteitskliniek Twente B.V.
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- M.F.G. Verberg
- Principal Investigator Email
- m.verberg@fertiliteitskliniektwente.nl
- Contact Person Name
- M.F.G. Verberg
- Contact Person Email
- m.verberg@fertiliteitskliniektwente.nl
- Site Name
- Ikazia Ziekenhuis
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- B. Torrenga
- Principal Investigator Email
- b.torrenga@ikazia.nl
- Contact Person Name
- B. Torrenga
- Contact Person Email
- b.torrenga@ikazia.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- A.E.P. Cantineau-Gielkens
- Principal Investigator Email
- a.e.p.cantineau@umcg.nl
- Contact Person Name
- A.E.P. Cantineau-Gielkens
- Contact Person Email
- a.e.p.cantineau@umcg.nl
- Site Name
- Maxima Medisch Centrum
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- B.J. Van der Knoop
- Principal Investigator Email
- b.vanderknoop@mmc.nl
- Contact Person Name
- B.J. Van der Knoop
- Contact Person Email
- b.vanderknoop@mmc.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- M.C. De Hundt
- Principal Investigator Email
- m.d.hundt@nwz.nl
- Contact Person Name
- M.C. De Hundt
- Contact Person Email
- m.d.hundt@nwz.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- G. De Krom
- Principal Investigator Email
- g.dekrom@zuyderland.nl
- Contact Person Name
- G. De Krom
- Contact Person Email
- g.dekrom@zuyderland.nl
- Site Name
- Amphia Hospital
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- J. Visser
- Principal Investigator Email
- VisserJ8@amphia.nl
- Contact Person Name
- J. Visser
- Contact Person Email
- VisserJ8@amphia.nl
- Site Name
- Deventer Ziekenhuis
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- J. van den Berg
- Principal Investigator Email
- wetenschapsbureau@dz.nl
- Contact Person Name
- J. van den Berg
- Contact Person Email
- wetenschapsbureau@dz.nl
- Site Name
- ETZ Elisabeth
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- I.A.J. van Rooij
- Principal Investigator Email
- i.vanrooij@etz.nl
- Contact Person Name
- I.A.J. van Rooij
- Contact Person Email
- i.vanrooij@etz.nl
- Site Name
- Treant Ziekenhuiszorg Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- S.B.M. Gaykema
- Principal Investigator Email
- s.gaykema@treant.nl
- Contact Person Name
- S.B.M. Gaykema
- Contact Person Email
- s.gaykema@treant.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- T. Dahhan
- Principal Investigator Email
- t.dahhan@umcutrecht.nl
- Contact Person Name
- T. Dahhan
- Contact Person Email
- t.dahhan@umcutrecht.nl
- Site Name
- Catharina Ziekenhuis Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- M.M.E. Van Rumste
- Principal Investigator Email
- minouche.v.rumste@catharinaziekenhuis.nl
- Contact Person Name
- M.M.E. Van Rumste
- Contact Person Email
- minouche.v.rumste@catharinaziekenhuis.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- M.L. Bandell
- Principal Investigator Email
- bandellm@asz.nl
- Contact Person Name
- M.L. Bandell
- Contact Person Email
- bandellm@asz.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- M. Goddijn
- Principal Investigator Email
- m.goddijn@amsterdamumc.nl
- Contact Person Name
- M. Goddijn
- Contact Person Email
- m.goddijn@amsterdamumc.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- S.C.J.P. Gielen
- Principal Investigator Email
- wetenschapsbureau@franciscus.nl
- Contact Person Name
- S.C.J.P. Gielen
- Contact Person Email
- wetenschapsbureau@franciscus.nl
- Site Name
- Elkerliek Ziekenhuis
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- J. Kortekaas
- Principal Investigator Email
- jc.kortekaas@elkerliek.nl
- Contact Person Name
- J. Kortekaas
- Contact Person Email
- jc.kortekaas@elkerliek.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- L.E.E. Van der Houwen
- Principal Investigator Email
- lisette.vanderhouwen@radboudumc.nl
- Contact Person Name
- L.E.E. Van der Houwen
- Contact Person Email
- lisette.vanderhouwen@radboudumc.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- F. Janse
- Principal Investigator Email
- fjanse@rijnstate.nl
- Contact Person Name
- F. Janse
- Contact Person Email
- fjanse@rijnstate.nl
- Site Name
- Nij Geertgen Centrum voor vruchtbaarheid B.V.
- Department Name
- Gynecology
- Principal Investigator Name
- K. Fleischer
- Principal Investigator Email
- kathrin.fleischer@nijgeertgen.nl
- Contact Person Name
- K. Fleischer
- Contact Person Email
- kathrin.fleischer@nijgeertgen.nl
- Site Name
- Tergooiziekenhuizen
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- C. De Koning
- Principal Investigator Email
- CdeKoning@tergooi.nl
- Contact Person Name
- C. De Koning
- Contact Person Email
- CdeKoning@tergooi.nl
- Site Name
- Ziekenhuis Gelderse Vallei Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- A.J.C.M. Van Dongen
- Principal Investigator Email
- dongena@zgv.nl
- Contact Person Name
- A.J.C.M. Van Dongen
- Contact Person Email
- dongena@zgv.nl
- Site Name
- Canisius Wilhelmina Ziekenhuis
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- C.F. van Heteren
- Principal Investigator Email
- c.v.heteren@cwz.nl
- Contact Person Name
- C.F. van Heteren
- Contact Person Email
- c.v.heteren@cwz.nl
- Site Name
- Jeroen Bosch Ziekenhuis Stichting
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- J.P. De Bruin
- Principal Investigator Email
- j.d.bruin@jbz.nl
- Contact Person Name
- J.P. De Bruin
- Contact Person Email
- j.d.bruin@jbz.nl
- Site Name
- Stichting OLVG
- Department Name
- Obstrics & Gynecology
- Principal Investigator Name
- H.R. Verhoeve
- Principal Investigator Email
- H.R.Verhoeve@olvg.nl
- Contact Person Name
- H.R. Verhoeve
- Contact Person Email
- H.R.Verhoeve@olvg.nl
- Site Name
- Frisius MC
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- D.A.M. Perquin
- Principal Investigator Email
- denise.perquin@frisiusmc.nl
- Contact Person Name
- D.A.M. Perquin
- Contact Person Email
- denise.perquin@frisiusmc.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- LETROZOLE
- Active Substance
- LETROZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 7.5 mg per day
- Investigational Product Name
- HUMAN MENOPAUSAL GONADOTROPHINS
- Active Substance
- HUMAN MENOPAUSAL GONADOTROPHINS
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Maximum Dose
- 225 mg per day (max daily amount stated in product entry)
- Investigational Product Name
- FOLLITROPIN ALFA
- Active Substance
- FOLLITROPIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Maximum Dose
- 225 IU per day (max daily amount stated in product entry)
Related trials
Other published trials that may interest you.
- metformin for Polycystic ovary syndrome
- METFORMIN HYDROCHLORIDE for Polycystic ovary syndrome
- Estradiol for Diabetes mellitus | Perimenopause | Early postmenopause
- CHLORMADINONE ACETATE, ETHINYLESTRADIOL for Hormonal contraception
- MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE for Postoperative hypoparathyroidism