Polycystic Ovarian Syndrome Clinical Trial
Official title:
Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa
This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02244567 -
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women
|
Phase 1 | |
| Completed |
NCT01672801 -
Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT
|
N/A | |
| Completed |
NCT00579540 -
Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels
|
N/A | |
| Terminated |
NCT05084274 -
Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program
|
N/A | |
| Completed |
NCT03717935 -
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS
|
N/A | |
| Withdrawn |
NCT01716429 -
Healthy Eating for Reproductive Health: Greenville
|
N/A | |
| Active, not recruiting |
NCT02896452 -
Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome
|
||
| Recruiting |
NCT05146063 -
LNK in Polycystic Ovary Syndrome With Insulin Resistance
|
||
| Recruiting |
NCT06303219 -
Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome
|
N/A | |
| Completed |
NCT02869750 -
The Relationship Between Adipokines, Obesity and Insulin Resistance in Women With Polycystic Ovarian Syndrome
|
||
| Completed |
NCT01237106 -
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
|
N/A | |
| Completed |
NCT01185704 -
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
|
Phase 3 | |
| Recruiting |
NCT04029805 -
Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels
|
Phase 1/Phase 2 | |
| Completed |
NCT01675843 -
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
|
Phase 4 | |
| Completed |
NCT01577017 -
The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS)
|
Phase 3 | |
| Completed |
NCT00478504 -
Letrozole Versus Clomifene Citrate for Ovulation Induction
|
Phase 4 | |
| Completed |
NCT05215223 -
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
|
N/A | |
| Completed |
NCT03358199 -
LOD Before IVF/ICSI in PCOS Patients With High AMH
|
N/A | |
| Completed |
NCT02436226 -
Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
|
Phase 4 | |
| Recruiting |
NCT02084940 -
Long Acting GnRH Antagonist in PCOS Women Undergoing IVF
|
N/A |