Trial Outcomes & Findings for Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction (NCT NCT01081626)
NCT ID: NCT01081626
Last Updated: 2014-02-13
Results Overview
Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (\>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
310 participants
Primary outcome timeframe
Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Results posted on
2014-02-13
Participant Flow
Participant milestones
| Measure |
Chronic Low Dose (CLD) Protocol
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
155
|
|
Overall Study
Assessed for Efficacy
|
122
|
125
|
|
Overall Study
COMPLETED
|
95
|
94
|
|
Overall Study
NOT COMPLETED
|
60
|
61
|
Reasons for withdrawal
| Measure |
Chronic Low Dose (CLD) Protocol
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Overall Study
Dosing error
|
1
|
1
|
|
Overall Study
Missing Estradiol
|
25
|
28
|
|
Overall Study
Low antral follicle count
|
1
|
0
|
|
Overall Study
Overstimulation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Other
|
33
|
30
|
Baseline Characteristics
Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction
Baseline characteristics by cohort
| Measure |
Chronic Low Dose (CLD) Protocol
n=122 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=125 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.51 years
STANDARD_DEVIATION 4.42 • n=5 Participants
|
27.88 years
STANDARD_DEVIATION 4.33 • n=7 Participants
|
27.70 years
STANDARD_DEVIATION 4.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})Population: The Intention-To-Treat (ITT) population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.
Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (\>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=122 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=125 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Percentage of Participants With a Mono-follicular Development
|
56.55 percentage of participants
|
55.20 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})Population: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.
Multi-follicular development was defined as the development of more than 3 follicles \>= 15 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=122 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=125 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants With Multi-follicular Development
|
17 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})Population: The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit.
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=155 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=155 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
30 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})Population: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.
Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning-identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=94 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=91 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants With Multiple Pregnancies
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})Population: The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit. Number of participants analyzed (N) included participants who were evaluated for this particular measure.
Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=73 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=77 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants With Injection Tolerability
|
54 participants
|
54 participants
|
SECONDARY outcome
Timeframe: End of stimulation cycle (less than or equal to [<=] 35 days)Population: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=122 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=125 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants Who Received Human Chorionic Gonadotropin (hCG)
|
94 participants
|
91 participants
|
SECONDARY outcome
Timeframe: End of stimulation cycle (less than or equal to [<=] 35 days)Population: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.
Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=122 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=125 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants With Cancelled Cycles
|
19 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})Population: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.
Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=94 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=91 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants With Clinical Pregnancies
|
19 participants
|
18 participants
|
SECONDARY outcome
Timeframe: End of stimulation cycle (less than or equal to [<=] 35 days)Population: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=94 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=91 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Duration of Follicle Stimulating Hormone (FSH)
|
13.68 Days
Standard Deviation 6.33
|
12.85 Days
Standard Deviation 5.58
|
SECONDARY outcome
Timeframe: End of stimulation cycle (less than or equal to [<=] 35 daysPopulation: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=94 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=91 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Total Follicle Stimulating Hormone (FSH) Dose
|
1119.41 IU
Standard Deviation 690.04
|
1155.47 IU
Standard Deviation 730.45
|
SECONDARY outcome
Timeframe: On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})Population: The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.
Ease of use of Gonal-f® pen was assessed through a questionnaire consisting of 23 questions and the number of participants who responded to the questionnaire was recorded.
Outcome measures
| Measure |
Chronic Low Dose (CLD) Protocol
n=122 Participants
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=125 Participants
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire
|
58 participants
|
75 participants
|
Adverse Events
Chronic Low Dose (CLD) Protocol
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Low Dose (LD) Protocol
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chronic Low Dose (CLD) Protocol
n=155 participants at risk
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=155 participants at risk
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
Reproductive system and breast disorders
Ectopic pregnancy
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
Other adverse events
| Measure |
Chronic Low Dose (CLD) Protocol
n=155 participants at risk
Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
Low Dose (LD) Protocol
n=155 participants at risk
Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Cardiac disorders
Dizziness
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
3.2%
5/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Burning pain of the stomach
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Abdominal colic pain
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
1.3%
2/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
12/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
4.5%
7/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Gums swelling
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Heart burn
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
In abdomen
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Lower abdominal pain
|
1.3%
2/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
5/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
3.2%
5/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Pain in stomach
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
2.6%
4/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Burning
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Fever
|
1.3%
2/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Generalized fatigability
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Pain
|
1.3%
2/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Spasm and pain
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Chest pain
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
1.9%
3/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Hot flash
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Immune system disorders
Allergic rhinitis
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
3/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
1.9%
3/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in the foot
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in the right loin
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Legs pain
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
1.3%
2/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Musculoskeletal and connective tissue disorders
Weakness Generalized
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Body pain
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Nervous system disorders
Headache
|
6.5%
10/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
9.0%
14/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Psychiatric disorders
Drowsiness
|
1.3%
2/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Psychiatric disorders
Insomnia
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Psychiatric disorders
Nervousness
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Psychiatric disorders
Lethargy
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Reproductive system and breast disorders
Ectopic pregnancy
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Reproductive system and breast disorders
Ovarian Hyper Stimulation Syndrome
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Blood
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
General disorders
Car accident (spotting)
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Skin and subcutaneous tissue disorders
Itching in upper and lower limb and abdomen
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Skin and subcutaneous tissue disorders
Insect bite
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
|
Skin and subcutaneous tissue disorders
Itching and burning
|
0.00%
0/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
0.65%
1/155 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs were recorded until the post-treatment safety, on day 35-42 post-hCG administration.
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 35- 42 for participants who completed the study.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER