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Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01081626
Recruitment Status : Completed
First Posted : March 5, 2010
Results First Posted : November 7, 2012
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Merck Serono Middle East FZ-LLC, United Arab Emirates, an affiliate of Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovulation Induction
Intervention Drug: Recombinant FSH (follitropin alpha)
Enrollment 310
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 155 155
Assessed for Efficacy 122 125
Completed 95 94
Not Completed 60 61
Reason Not Completed
Dosing error             1             1
Missing Estradiol             25             28
Low antral follicle count             1             0
Overstimulation             0             1
Lost to Follow-up             0             1
Other             33             30
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 122 125 247
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 125 participants 247 participants
27.51  (4.42) 27.88  (4.33) 27.70  (4.37)
[1]
Measure Description: Data for baseline measure (age) was available for 122 and 125 participants in CLD protocol and LD protocol arm, respectively, who were treated and had at least 1 efficacy evaluation.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 125 participants 247 participants
Female
122
 100.0%
125
 100.0%
247
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Data for baseline measure (gender) was available for 122 and 125 participants in CLD protocol and LD protocol arm, respectively, who were treated and had at least 1 efficacy evaluation.
1.Primary Outcome
Title Percentage of Participants With a Mono-follicular Development
Hide Description 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.
Time Frame 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})
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 122 125
Measure Type: Number
Unit of Measure: percentage of participants
56.55 55.20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chronic Low Dose (CLD) Protocol, Low Dose (LD) Protocol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9560
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0135
Confidence Interval (2-Sided) 95%
-0.1325 to 0.1637
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Multi-follicular Development
Hide Description 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.
Time Frame Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 122 125
Measure Type: Number
Unit of Measure: participants
17 15
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chronic Low Dose (CLD) Protocol, Low Dose (LD) Protocol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7924
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.088
Confidence Interval (2-Sided) 95%
0.7642 to 1.5490
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.
Time Frame Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 155 155
Measure Type: Number
Unit of Measure: participants
30 31
4.Secondary Outcome
Title Number of Participants With Multiple Pregnancies
Hide Description 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.
Time Frame Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: participants
3 1
5.Secondary Outcome
Title Number of Participants With Injection Tolerability
Hide Description Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.
Time Frame Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 73 77
Measure Type: Number
Unit of Measure: participants
54 54
6.Secondary Outcome
Title Number of Participants Who Received Human Chorionic Gonadotropin (hCG)
Hide Description [Not Specified]
Time Frame End of stimulation cycle (less than or equal to [<=] 35 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 122 125
Measure Type: Number
Unit of Measure: participants
94 91
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chronic Low Dose (CLD) Protocol, Low Dose (LD) Protocol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5331
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Cancelled Cycles
Hide Description Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.
Time Frame End of stimulation cycle (less than or equal to [<=] 35 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 122 125
Measure Type: Number
Unit of Measure: participants
19 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chronic Low Dose (CLD) Protocol, Low Dose (LD) Protocol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9351
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.015
Confidence Interval (2-Sided) 95%
0.7175 to 1.4350
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Clinical Pregnancies
Hide Description 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.
Time Frame Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: participants
19 18
9.Secondary Outcome
Title Duration of Follicle Stimulating Hormone (FSH)
Hide Description [Not Specified]
Time Frame End of stimulation cycle (less than or equal to [<=] 35 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 94 91
Mean (Standard Deviation)
Unit of Measure: Days
13.68  (6.33) 12.85  (5.58)
10.Secondary Outcome
Title Total Follicle Stimulating Hormone (FSH) Dose
Hide Description [Not Specified]
Time Frame End of stimulation cycle (less than or equal to [<=] 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 94 91
Mean (Standard Deviation)
Unit of Measure: IU
1119.41  (690.04) 1155.47  (730.45)
11.Secondary Outcome
Title Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire
Hide Description 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.
Time Frame On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 122 125
Measure Type: Number
Unit of Measure: participants
58 75
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/155 (0.00%)   1/155 (0.65%) 
Reproductive system and breast disorders     
Ectopic pregnancy * 1  0/155 (0.00%)  1/155 (0.65%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chronic Low Dose (CLD) Protocol Low Dose (LD) Protocol
Affected / at Risk (%) Affected / at Risk (%)
Total   30/155 (19.35%)   30/155 (19.35%) 
Cardiac disorders     
Dizziness * 1  1/155 (0.65%)  5/155 (3.23%) 
Gastrointestinal disorders     
Burning pain of the stomach * 1  0/155 (0.00%)  1/155 (0.65%) 
Abdominal colic pain * 1  0/155 (0.00%)  2/155 (1.29%) 
Abdominal pain * 1  12/155 (7.74%)  7/155 (4.52%) 
Gums swelling * 1  0/155 (0.00%)  1/155 (0.65%) 
Heart burn * 1  0/155 (0.00%)  1/155 (0.65%) 
In abdomen * 1  0/155 (0.00%)  1/155 (0.65%) 
Lower abdominal pain * 1  2/155 (1.29%)  1/155 (0.65%) 
Nausea * 1  5/155 (3.23%)  5/155 (3.23%) 
Pain in stomach * 1  0/155 (0.00%)  4/155 (2.58%) 
Vomiting * 1  0/155 (0.00%)  1/155 (0.65%) 
Abdominal bloating * 1  1/155 (0.65%)  0/155 (0.00%) 
General disorders     
Burning * 1  1/155 (0.65%)  0/155 (0.00%) 
Fever * 1  2/155 (1.29%)  0/155 (0.00%) 
Generalized fatigability * 1  1/155 (0.65%)  0/155 (0.00%) 
Pain * 1  2/155 (1.29%)  0/155 (0.00%) 
Spasm and pain * 1  1/155 (0.65%)  0/155 (0.00%) 
Chest pain * 1  0/155 (0.00%)  3/155 (1.94%) 
Fatigue * 1  0/155 (0.00%)  1/155 (0.65%) 
Hot flash * 1  0/155 (0.00%)  1/155 (0.65%) 
Body pain * 1  0/155 (0.00%)  1/155 (0.65%) 
Blood * 1  0/155 (0.00%)  1/155 (0.65%) 
Car accident (spotting) * 1  1/155 (0.65%)  0/155 (0.00%) 
Immune system disorders     
Allergic rhinitis * 1  1/155 (0.65%)  0/155 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/155 (1.94%)  3/155 (1.94%) 
Joint pain * 1  0/155 (0.00%)  1/155 (0.65%) 
Pain in the foot * 1  1/155 (0.65%)  0/155 (0.00%) 
Pain in the right loin * 1  1/155 (0.65%)  0/155 (0.00%) 
Legs pain * 1  0/155 (0.00%)  1/155 (0.65%) 
Lower back pain * 1  0/155 (0.00%)  2/155 (1.29%) 
Weakness Generalized * 1  0/155 (0.00%)  1/155 (0.65%) 
Nervous system disorders     
Headache * 1  10/155 (6.45%)  14/155 (9.03%) 
Psychiatric disorders     
Drowsiness * 1  2/155 (1.29%)  0/155 (0.00%) 
Insomnia * 1  1/155 (0.65%)  1/155 (0.65%) 
Nervousness * 1  1/155 (0.65%)  0/155 (0.00%) 
Anxiety * 1  0/155 (0.00%)  1/155 (0.65%) 
Lethargy * 1  0/155 (0.00%)  1/155 (0.65%) 
Reproductive system and breast disorders     
Breast pain * 1  0/155 (0.00%)  1/155 (0.65%) 
Ectopic pregnancy * 1  0/155 (0.00%)  1/155 (0.65%) 
Ovarian Hyper Stimulation Syndrome * 1  1/155 (0.65%)  0/155 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cold * 1  1/155 (0.65%)  1/155 (0.65%) 
Skin and subcutaneous tissue disorders     
Itching in upper and lower limb and abdomen * 1  1/155 (0.65%)  0/155 (0.00%) 
Insect bite * 1  0/155 (0.00%)  1/155 (0.65%) 
Itching * 1  0/155 (0.00%)  1/155 (0.65%) 
Itching and burning * 1  0/155 (0.00%)  1/155 (0.65%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01081626    
Other Study ID Numbers: EMR 700623-501
First Submitted: March 4, 2010
First Posted: March 5, 2010
Results First Submitted: September 3, 2012
Results First Posted: November 7, 2012
Last Update Posted: February 13, 2014