Female infertility MedDRA version: 15.1 Level: LLT Classification code 10003540 Term: Assisted fertilization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Duphaston 10 mg comprimés pelliculés
Pharmaceutical Form: Tablet
INN or Proposed INN: DYDROGESTERONE
CAS Number: 152-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Abbott Laboratories GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent; 2. Premenopausal females, age > 18 years =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study; 2. Acute urogenital disease 3. Known allergic reactions to progesterone products 4. Known allergic reactions to peanuts and peanut oil 5. Intake of experimental drug or participation in any other clinical trial within 30 days prior to study start 6. Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects to participate in or to complete the study 7. Current or recent substance abuse, including alcohol and tobacco (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed) 8. History of chemotherapy or radiotherapy 9. Patients with more than 3 unsuccessful IVF attempts 10. Contraindication for pregnancy 11. Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests 12. History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate non-inferiority of oral dydrogesterone 10 mg TID versus micronized progesterone vaginal capsules 200 mg TID. The primary efficacy parameter is the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound.;Secondary Objective: The secondary objectives and parameters are a positive pregnancy test on Day 14 after embryo transfer, the incidence of live births and healthy newborns. The safety objective is to obtain safety and tolerability data by means of documentation of treatment emergent adverse events (TEAE) during the entire study period. In addition, data on vital signs, physical examination findings, and routine laboratory values will be obtained. Furthermore, signs and symptoms of threatened abortion, the rate of hypospadias and the rate of masculinization in female babies will be recorded. The time of delivery (pregnancy week) and the following parameters of the newborn will be obtained at delivery: gender, APGAR Score, weight, height, head circumference, abnormal findings of physical examination and any malformations.;Primary end point(s): The primary efficacy parameter is the pregnancy rate defined as the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound. ;Timepoint(s) of evaluation of this end point: 12 weeks’ gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer, the incidence of live births and healthy newborns. Further secondary parameters are gender and APGAR score as well as the height, weight and head circumference of the newborn (s). In addition, a physical examination of the newborn will be performed and any malformations will be recorded. ;Timepoint(s) of evaluation of this end point: Day 14 after embryo transfer and birth | — |
Countries
Austria, Belgium, Finland, India, Israel, Russian Federation, Spain
Contacts
Public ContactSimone Schicker
Quintiles GmbH
Outcome results
None listed