A Phase 3 interventional study of MSJ-0011 and urinary hCG (u-hCG) in Anovulation, Oligo-ovulation and Hypothalamic-pituitary Dysfunction, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 6 sites in Japan. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2016-01-07.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 3, Interventional, and Treatment
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.
75 studies on the registry are indexed under Anovulation; 7 are open to participants now.
This study's enrollment of 81 is close to the median of 80 across 52 interventional studies indexed under Anovulation.
Browse Anovulation studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: MSJ-0011 · Drug: Follitropin alpha
Drug: urinary hCG (u-hCG) · Drug: Follitropin alpha
Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 250 microgram (mcg) MSJ-0011 (choriogonadotropin alfa \[recombinant human Chorionic Gonadotropin, r-hCG\]) subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \>=18 mm; not more than 3 follicles each with a mean diameter of \>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
Low-dose step-up protocol involves starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days (Day 8, 15, 28) will be done if no ovarian response will be observed for maximum of 28 days.
Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy
Ovulation was defined as mid-luteal serum progesterone level of \>= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).
Time frame: Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment
Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy
Ovulation was defined as mid-luteal serum progesterone level of \>= 9.4 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.
Time frame: Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment
Mid-luteal Endometrial Thickness
Endometrial thickness was measured using TVUS.
Time frame: Day 5 to 7 post hCG treatment
Percentage of Participants With Biochemical Pregnancy
Percentage of subjects with biochemical pregnancy was assessed. Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS on the Day 35 to 42 post hCG treatment, but with a positive serum β-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than \[\>\] 10 IU/Liter)
Time frame: Day 35 to 42 post hCG treatment
Percentage of Participants With Clinical Pregnancy
Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.
Time frame: Day 35 to 42 post hCG treatment
| Milestone | MSJ-0011 | u-hCG |
|---|---|---|
| Started | 54 | 27 |
| Completed | 50 | 27 |
| Not completed | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Investigator discretion | 3 | 0 |
Ovulation was defined as mid-luteal serum progesterone level of \>= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).
| percentage of subjects | MSJ-0011 | u-hCG |
|---|---|---|
| Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy | 100 (93.4 to 100) | 100 (87.2 to 100) |
Ovulation was defined as mid-luteal serum progesterone level of \>= 9.4 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.
| percentage of subjects | MSJ-0011 | u-hCG |
|---|---|---|
| Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy | 96.3 (87.3 to 99.5) | 88.9 (70.8 to 97.6) |
Endometrial thickness was measured using TVUS.
| millimeter | MSJ-0011 | u-hCG |
|---|---|---|
| Mid-luteal Endometrial Thickness | 11.6 ± 2.64 | 12.4 ± 2.58 |
Percentage of subjects with biochemical pregnancy was assessed. Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS on the Day 35 to 42 post hCG treatment, but with a positive serum β-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than \[\>\] 10 IU/Liter)
| percentage of subjects | MSJ-0011 | u-hCG |
|---|---|---|
| Percentage of Participants With Biochemical Pregnancy | 3.7 (0.5 to 12.7) | 3.7 (0.1 to 19.0) |
Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.
| percentage of subjects | MSJ-0011 | u-hCG |
|---|---|---|
| Percentage of Participants With Clinical Pregnancy | 29.6 (18.0 to 43.6) | 33.3 (16.5 to 54.0) |
Collected over From signing of the informed consent document until Day 28-31 (for subjects who had a negative serum β-hCG pregnancy test on Day 15-20), or up to the Day 35-42 post hCG treatment (for subjects who have a positive serum β-hCG pregnancy test on Day 15-20).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MSJ-0011 | — | 1/54 (1.9%) | 32/54 (59.3%) |
| u-hCG | — | 0/27 (0%) | 11/27 (40.7%) |
| Event | MSJ-0011 | u-hCG |
|---|---|---|
| Ovarian hyperstimulation syndromeReproductive system and breast disorders | 1/54 | 0/27 |
| Event | MSJ-0011 | u-hCG |
|---|---|---|
| Ovarian hyperstimulation syndromeReproductive system and breast disorders | 7/54 | 4/27 |
| Injection site painGeneral disorders | 2/54 | 3/27 |
| Ovarian cystReproductive system and breast disorders | 6/54 | 3/27 |
| Injection site erythemaGeneral disorders | 5/54 | 2/27 |
| CystitisInfections and infestations | 4/54 | 0/27 |
| NasopharyngitisInfections and infestations | 4/54 | 1/27 |
| Abdominal distensionGastrointestinal disorders | 0/54 | 1/27 |
| Abdominal painGastrointestinal disorders | 2/54 | 0/27 |
| ConstipationGastrointestinal disorders | 2/54 | 0/27 |
| Abdominal pain upperGastrointestinal disorders | 1/54 | 0/27 |
Safety population included all the subjects who received investigational medicinal product (\[IMP\]; MSJ-0011 or u-hCG)
| Age, Continuous(years) | MSJ-0011 | Urinary Human Chorionic Gonadotropin (u-hCG) | Total |
|---|---|---|---|
| Mean | 32.61 ± 3.303 | 30.67 ± 3.603 | 31.96 ± 3.506 |
| Sex: Female, Male(Participants) | MSJ-0011 | Urinary Human Chorionic Gonadotropin (u-hCG) | Total |
|---|---|---|---|
| Female | 54 | 27 | 81 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany →