Trial · NCT01653743
Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
NCT01653743, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2016-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women. Trials, record NCT01653743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01653743
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
- NCT number
- NCT01653743
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Anovulation, Oligo-ovulation, Hypothalamic-pituitary Dysfunction, Polycystic Ovarian Syndrome
- Interventions
- MSJ-0011, urinary hCG (u-hCG), Follitropin alpha
- First posted
- 2012-07-31
- Last updated
- 2016-01-07
- Results first posted
- 2016-01-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment | 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). |
| Secondary | 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 | Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment | 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. |
| Secondary | Mid-luteal Endometrial Thickness | Day 5 to 7 post hCG treatment | Endometrial thickness was measured using TVUS. |
| Secondary | Percentage of Participants With Biochemical Pregnancy | Day 35 to 42 post hCG treatment | 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) |
| Secondary | Percentage of Participants With Clinical Pregnancy | Day 35 to 42 post hCG treatment | Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment | The modified intent to treat (Mod ITT) population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment. | percentage of subjects | NUMBER |
| SECONDARY | 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 | Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment | The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment. | percentage of subjects | NUMBER |
| SECONDARY | Mid-luteal Endometrial Thickness | Day 5 to 7 post hCG treatment | The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment. | millimeter | MEAN |
| SECONDARY | Percentage of Participants With Biochemical Pregnancy | Day 35 to 42 post hCG treatment | The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Pregnancy | Day 35 to 42 post hCG treatment | The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | MSJ-0011 | 100 | 95% Confidence Interval 93.4 to 100 | percentage of subjects | |
| 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 | u-hCG | 100 | 95% Confidence Interval 87.2 to 100 | percentage of subjects | |
| 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 | MSJ-0011 | 96.3 | 95% Confidence Interval 87.3 to 99.5 | percentage of subjects | |
| 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 | u-hCG | 88.9 | 95% Confidence Interval 70.8 to 97.6 | percentage of subjects | |
| Mid-luteal Endometrial Thickness | MSJ-0011 | 11.6 | Standard Deviation 2.64 | millimeter | |
| Mid-luteal Endometrial Thickness | u-hCG | 12.4 | Standard Deviation 2.58 | millimeter | |
| Percentage of Participants With Biochemical Pregnancy | MSJ-0011 | 3.7 | 95% Confidence Interval 0.5 to 12.7 | percentage of subjects | |
| Percentage of Participants With Biochemical Pregnancy | u-hCG | 3.7 | 95% Confidence Interval 0.1 to 19.0 | percentage of subjects | |
| Percentage of Participants With Clinical Pregnancy | MSJ-0011 | 29.6 | 95% Confidence Interval 18.0 to 43.6 | percentage of subjects | |
| Percentage of Participants With Clinical Pregnancy | u-hCG | 33.3 | 95% Confidence Interval 16.5 to 54.0 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MSJ-0011 | 54 | |
| Overall Study | STARTED | u-hCG | 27 | |
| Overall Study | COMPLETED | MSJ-0011 | 50 | |
| Overall Study | COMPLETED | u-hCG | 27 | |
| Overall Study | NOT COMPLETED | MSJ-0011 | 4 | |
| Overall Study | NOT COMPLETED | u-hCG | 0 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | MSJ-0011 | 0 | 54 | |
| other | Abdominal distension | Gastrointestinal disorders | u-hCG | 1 | 27 | |
| other | Abdominal pain | Gastrointestinal disorders | MSJ-0011 | 2 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | u-hCG | 0 | 27 | |
| other | Abdominal pain upper | Gastrointestinal disorders | MSJ-0011 | 1 | 54 | |
| other | Abdominal pain upper | Gastrointestinal disorders | u-hCG | 0 | 27 | |
| other | Ascites | Gastrointestinal disorders | MSJ-0011 | 1 | 54 | |
| other | Ascites | Gastrointestinal disorders | u-hCG | 0 | 27 | |
| other | Constipation | Gastrointestinal disorders | MSJ-0011 | 2 | 54 | |
| other | Constipation | Gastrointestinal disorders | u-hCG | 0 | 27 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MSJ-0011 | ||
| Total, all-cause mortality | u-hCG | ||
| Total, other adverse events | MSJ-0011 | 32 | 54 |
| Total, other adverse events | u-hCG | 11 | 27 |
| Total, serious adverse events | MSJ-0011 | 1 | 54 |
| Total, serious adverse events | u-hCG | 0 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MSJ-0011 vs u-hCG: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01653743
GET https://conductscience.org/api/trials/v1/NCT01653743/events?page=2