Clinical trial • Phase III • Other
PROGESTERONE for Infertility
Phase III trial of PROGESTERONE for Infertility.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Infertility
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-04-2024
- First CTIS Authorization Date
- 23-04-2024
Trial design
Randomised, intervention arms compare two formulations of vaginal micronized progesterone: standard formulation (200 mg tid) versus new formulation (400 mg bid). a comparator product used for endometrial preparation is estradiol besins 0,75 mg/dose (transdermal gel).-controlled Phase III trial across 5 sites in Spain.
- Randomised
- Yes
- Comparator
- Intervention arms compare two formulations of vaginal micronized progesterone: standard formulation (200 mg tid) versus new formulation (400 mg bid). A comparator product used for endometrial preparation is Estradiol Besins 0,75 mg/dose (transdermal gel).
- Target Sample Size
- 1020
Eligibility
Recruits 1020 No vulnerable populations selected (isVulnerablePopulationSelected: false). The trial enrols adult female participants (age 18-43 or <50 for egg donation). A subject information and informed consent form is listed in the documents (L1_HIPCI MI-PROF_ESP V1 15092022); no mention of assent or specific consent handling for minors or other vulnerable groups in the available data..
- Pregnancy Exclusion
- pregnancy or lactation
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). The trial enrols adult female participants (age 18-43 or <50 for egg donation). A subject information and informed consent form is listed in the documents (L1_HIPCI MI-PROF_ESP V1 15092022); no mention of assent or specific consent handling for minors or other vulnerable groups in the available data.
Inclusion criteria
- {"criterion_text":"- patients undergoing an artificial cycle-frozen embryo transfer (AC-FET)\n- Endometrial preparation with hormone replacement therapy\n- Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)\n- Age < 50 years following an egg donation cycle\n- BMI > 18 and < 30 kg/m2\n- blastocyst embryo transfer\n- Willing to participate in the study\n- Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation."}
Exclusion criteria
- {"criterion_text":"- Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)\n- Hydrosalpinx\n- Recurrent pregnancy loss (≥ 3 previous miscarriages)\n- Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)\n- Allergy to study medication\n- pregnancy or lactation\n- Contraindication for hormonal treatment\n- Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test\n- Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary efficacy endpoint is the comparison of ongoing pregnancy rate. The primary efficacy endpoint is related to the primary trial objective.","definition_or_measurement_approach":"Comparison of ongoing pregnancy rate following luteal phase support with standard formulation (200mg tid) versus new formulation (400mg bid) vaginal micronized progesterone in patients undergoing an AC-FET; no precise numeric definition of 'ongoing pregnancy' provided in the available text."}
Secondary endpoints
- {"endpoint_text":"- Implantation rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Biochemical pregnancy rate","definition_or_measurement_approach":"Defined in the protocol as a pregnancy diagnosed only by the detection of bHCG in serum or urine."}
- {"endpoint_text":"- Clinical pregnancy rate","definition_or_measurement_approach":"Defined in the protocol as the presence of at least one embryo with heartbeat on transvaginal ultrasound."}
- {"endpoint_text":"- Miscarriage rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Frequency of adverse events","definition_or_measurement_approach":""}
Other endpoints
- {"endpoint_text":"- Live birth rate\n- Pregnancy complications\n- Preeclampsia\n- Preterm birth\n- Fetal growth restriction","definition_or_measurement_approach":"Post-study information endpoints listed as follow-up outcomes; specific definitions/measurement approaches not provided in the available text."}
Recruitment
- Planned Sample Size
- 1020
- Recruitment Window Months
- 22
- Consent Approach
- Informed consent is to be obtained from adult participants (participants are aged 18 years and above). A subject information and informed consent form is listed among the trial documents (L1_HIPCI MI-PROF_ESP V1 15092022). Languages and age-specific consent/assent procedures are not specified in the available data.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 1020
Spain
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 595
- Number Of Sites
- 5
- Number Of Participants
- 1020
Sites
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Nikolaos Polyzos
- Principal Investigator Email
- nikpol@dexeus.com
- Contact Person Name
- Nikolaos Polyzos
- Contact Person Email
- nikpol@dexeus.com
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Silvia Grau
- Principal Investigator Email
- silgra@dexeus.com
- Contact Person Name
- Silvia Grau
- Contact Person Email
- silgra@dexeus.com
- Site Name
- Hospital Quironsalud Del Valles
- Department Name
- Departmen of Reproductive Medicine
- Principal Investigator Name
- Silvia Grau
- Principal Investigator Email
- silgra@dexeus.com
- Contact Person Name
- Silvia Grau
- Contact Person Email
- silgra@dexeus.com
- Site Name
- Dexeus Mujer Reus
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Josep Gonzalo
- Principal Investigator Email
- josgon@dexeus.com
- Contact Person Name
- Josep Gonzalo
- Contact Person Email
- josgon@dexeus.com
- Site Name
- Dexeus Mujer Tarragona
- Department Name
- Department of Reproductive Medicine
- Principal Investigator Name
- Josep Gonzalo
- Principal Investigator Email
- josgon@dexeus.com
- Contact Person Name
- Josep Gonzalo
- Contact Person Email
- josgon@dexeus.com
Sponsor
Primary sponsor
- Full Name
- Santiago Dexeus Font Fundacio Privada
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Lugesteron 400 mg pehmeät emätinpuikot, kapselit
- Active Substance
- PROGESTERONE
- Modality
- Small molecule
- Routes Of Administration
- VAGINAL USE
- Route
- VAGINAL
- Authorisation Status
- Authorised
- Starting Dose
- 400 mg
- Dose Levels
- 400 mg (per suppository); max daily reported 800 mg
- Frequency
- bid (as described for the new formulation in the protocol)
- Maximum Dose
- 800 mg (maxDailyDoseAmount)
- Investigational Product Name
- PROGESTERONE, MICRONISED
- Active Substance
- PROGESTERONE, MICRONISED
- Modality
- Small molecule
- Routes Of Administration
- VAGINAL USE
- Route
- VAGINAL
- Authorisation Status
- Authorised
- Starting Dose
- 200 mg
- Dose Levels
- 200 mg (standard formulation as described in protocol, given tid in standard arm)
- Frequency
- tid (as described for the standard formulation in the protocol)
- Maximum Dose
- 600 mg (maxDailyDoseAmount field present for one product entry)
- Investigational Product Name
- Estradiol Besins 0,75 mg/dose, gel transdermique
- Active Substance
- ESTRADIOL HEMIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- TRANSDERMAL USE
- Route
- TRANSDERMAL
- Authorisation Status
- Authorised
- Starting Dose
- 0.75 mg/dose
- Dose Levels
- 0.75 mg/dose (per product SmPC)
- Maximum Dose
- 6 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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