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Trial record 100 of 107 for:    "21-hydroxylase deficiency"

Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women (OWL-PCOS)

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ClinicalTrials.gov Identifier: NCT00704912
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : December 17, 2015
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Polycystic Ovary Syndrome
Interventions Drug: Orlistat/Meal Replacement/Lifestyle Modification
Drug: Loestrin 1/20
Drug: Combination of treatments
Enrollment 217
Recruitment Details  
Pre-assignment Details 217 subjects consented for the study, of which 149 were randomized to one of the 3 treatment groups. Sixty-eight subjects were not randomized because they withdrew prior to randomization or were determined ineligible during the screening process.
Arm/Group Title Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Hide Arm/Group Description Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner. Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period. Combination of treatments: Medications will be administered as described for the other 2 arms.
Period Title: Overall Study
Started 50 49 50
Completed 44 45 43
Not Completed 6 4 7
Arm/Group Title Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined Total
Hide Arm/Group Description Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner. Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period. Combination of treatments: Medications will be administered as described for the other 2 arms. Total of all reporting groups
Overall Number of Baseline Participants 50 49 50 149
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 49 participants 50 participants 149 participants
28.6  (3.4) 29.8  (3.7) 28.7  (4.2) 29.0  (3.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 50 participants 149 participants
Female
50
 100.0%
49
 100.0%
50
 100.0%
149
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 50 participants 149 participants
Hispanic or Latino
6
  12.0%
6
  12.2%
5
  10.0%
17
  11.4%
Not Hispanic or Latino
44
  88.0%
43
  87.8%
45
  90.0%
132
  88.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 50 participants 149 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   4.0%
0
   0.0%
1
   2.0%
3
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  14.0%
7
  14.3%
14
  28.0%
28
  18.8%
White
35
  70.0%
40
  81.6%
31
  62.0%
106
  71.1%
More than one race
5
  10.0%
2
   4.1%
4
   8.0%
11
   7.4%
Unknown or Not Reported
1
   2.0%
0
   0.0%
0
   0.0%
1
   0.7%
Parity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 50 participants 149 participants
0 births 41 38 45 124
>0 births 9 11 5 25
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 50 participants 49 participants 50 participants 149 participants
96.0  (15.8) 94.6  (14.4) 95.2  (14.5) 95.3  (14.8)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 50 participants 49 participants 50 participants 149 participants
35.1  (4.6) 35.1  (4.2) 35.5  (4.4) 35.2  (4.4)
Metabolic Syndrome  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 50 participants 149 participants
Yes 18 14 21 53
No 31 34 29 94
Unknown 1 1 0 2
1.Primary Outcome
Title Live Birth Rate
Hide Description [Not Specified]
Time Frame Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Hide Arm/Group Description:
Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
Combination of treatments: Medications will be administered as described for the other 2 arms.
Overall Number of Participants Analyzed 50 49 50
Measure Type: Number
Unit of Measure: participants
13 5 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Oral Contraceptives (OCP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Log-binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.0 to 6.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Contraceptives (OCP), Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Log-binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
0.9 to 6.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Log-binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.5 to 2.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Ovulation Rate
Hide Description [Not Specified]
Time Frame Up to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Hide Arm/Group Description:
Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
Combination of treatments: Medications will be administered as described for the other 2 arms.
Overall Number of Participants Analyzed 50 49 50
Overall Number of Units Analyzed
Type of Units Analyzed: Clomiphene Treatment Cycles
136 154 140
Measure Type: Number
Unit of Measure: total number of ovulations
82 71 94
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Oral Contraceptives (OCP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Log-binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.0 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Contraceptives (OCP), Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log-binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1.1 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Log-binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.7 to 1.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Weight
Hide Description Change from baseline to end of the 4-month intervention.
Time Frame Baseline, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Hide Arm/Group Description:
Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
Combination of treatments: Medications will be administered as described for the other 2 arms.
Overall Number of Participants Analyzed 50 49 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kg
-6.2
(-7.1 to -5.3)
-1.1
(-2.0 to -0.3)
-6.1
(-7.0 to -5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Oral Contraceptives (OCP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Mean Change
Estimated Value -5.0
Confidence Interval (2-Sided) 95%
-6.3 to -3.8
Estimation Comments Lifestyle vs. OCP
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Contraceptives (OCP), Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Mean Change
Estimated Value -5.0
Confidence Interval (2-Sided) 95%
-6.2 to -3.7
Estimation Comments Combined vs. OCP
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Mean Change
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.3 to 1.2
Estimation Comments Lifestyle vs. Combined
4.Secondary Outcome
Title Prevalence of Metabolic Syndrome
Hide Description [Not Specified]
Time Frame Baseline, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Hide Arm/Group Description:
Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
Combination of treatments: Medications will be administered as described for the other 2 arms.
Overall Number of Participants Analyzed 50 49 50
Measure Type: Number
Unit of Measure: participants
Metabolic Syndrome at Baseline 18 14 21
Metabolic Syndrome at End of Intervention 18 21 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention
Comments Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.6 to 2.2
Estimation Comments End of intervention compared to baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Contraceptives (OCP)
Comments Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.4 to 4.3
Estimation Comments End of intervention compared to baseline
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lifestyle/OCP Combined
Comments Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.4 to 1.2
Estimation Comments End of intervention compared to baseline
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Oral Contraceptives (OCP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Oral Contraceptives (OCP), Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Lifestyle/OCP Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Hide Arm/Group Description Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner. Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period. Combination of treatments: Medications will be administered as described for the other 2 arms.
All-Cause Mortality
Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      0/49 (0.00%)      1/50 (2.00%)    
Gastrointestinal disorders       
Perforated appendix [1]  0/50 (0.00%)  0 0/49 (0.00%)  0 1/50 (2.00%)  1
Pregnancy, puerperium and perinatal conditions       
Ectopic pregnancy [2]  1/50 (2.00%)  1 0/49 (0.00%)  0 0/50 (0.00%)  0
Preterm delivery [3]  1/50 (2.00%)  1 0/49 (0.00%)  0 0/50 (0.00%)  0
Reproductive system and breast disorders       
Abnormal uterine bleeding [4]  1/50 (2.00%)  1 0/49 (0.00%)  0 0/50 (0.00%)  0
[1]
Postpartum hospitalization for perforated appendix
[2]
Ectopic pregnancy requiring surgery
[3]
Preterm delivery of twins at 20 weeks: 1 live birth and 1 IUFD secondary to infection
[4]
Episode of abnormal uterine bleeding leading to ER visit
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lifestyle Intervention Oral Contraceptives (OCP) Lifestyle/OCP Combined
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/50 (64.00%)      37/49 (75.51%)      43/50 (86.00%)    
Gastrointestinal disorders       
Steatorrhea/Diarrhea [1]  6/50 (12.00%)  0/49 (0.00%)  12/50 (24.00%) 
Constipation [1]  6/50 (12.00%)  1/49 (2.04%)  4/50 (8.00%) 
Gas/Bloating [1]  2/50 (4.00%)  2/49 (4.08%)  5/50 (10.00%) 
Dyspepsia [1]  2/50 (4.00%)  0/49 (0.00%)  3/50 (6.00%) 
Gas/Bloating [2]  4/44 (9.09%)  1/44 (2.27%)  3/43 (6.98%) 
Constipation [2]  2/44 (4.55%)  2/44 (4.55%)  3/43 (6.98%) 
General disorders       
Headache [1]  15/50 (30.00%)  14/49 (28.57%)  18/50 (36.00%) 
Nausea/Vomiting [1]  6/50 (12.00%)  7/49 (14.29%)  9/50 (18.00%) 
Abdominal Pain [1]  5/50 (10.00%)  1/49 (2.04%)  10/50 (20.00%) 
Dry Mouth [1]  4/50 (8.00%)  0/49 (0.00%)  1/50 (2.00%) 
Dizziness/Vertigo [1]  3/50 (6.00%)  2/49 (4.08%)  0/50 (0.00%) 
Fatigue [1]  1/50 (2.00%)  2/49 (4.08%)  3/50 (6.00%) 
Insomnia [1]  2/50 (4.00%)  0/49 (0.00%)  3/50 (6.00%) 
Tachycardia [1]  1/50 (2.00%)  0/49 (0.00%)  3/50 (6.00%) 
Headache [2]  4/44 (9.09%)  6/44 (13.64%)  12/43 (27.91%) 
Nausea/Vomiting [2]  5/44 (11.36%)  3/44 (6.82%)  5/43 (11.63%) 
Fatigue [2]  2/44 (4.55%)  1/44 (2.27%)  3/43 (6.98%) 
Abdominal Pain [2]  2/44 (4.55%)  3/44 (6.82%)  1/43 (2.33%) 
Visual Changes [2]  1/44 (2.27%)  0/44 (0.00%)  3/43 (6.98%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal Pain [1]  1/50 (2.00%)  3/49 (6.12%)  4/50 (8.00%) 
Back Pain [1]  1/50 (2.00%)  1/49 (2.04%)  3/50 (6.00%) 
Pregnancy, puerperium and perinatal conditions       
Nausea/Vomiting [3]  4/16 (25.00%)  0/8 (0.00%)  1/14 (7.14%) 
Fatigue [3]  3/16 (18.75%)  0/8 (0.00%)  1/14 (7.14%) 
Pelvic Pain [3]  3/16 (18.75%)  0/8 (0.00%)  1/14 (7.14%) 
Breast Pain [3]  1/16 (6.25%)  0/8 (0.00%)  2/14 (14.29%) 
Headache [3]  2/16 (12.50%)  0/8 (0.00%)  1/14 (7.14%) 
Mood Swings [3]  1/16 (6.25%)  0/8 (0.00%)  1/14 (7.14%) 
Constipation [3]  1/16 (6.25%)  0/8 (0.00%)  1/14 (7.14%) 
Hot flushes [3]  2/16 (12.50%)  0/8 (0.00%)  0/14 (0.00%) 
Spotting in pregnancy [3]  1/16 (6.25%)  0/8 (0.00%)  1/14 (7.14%) 
Hypertension [3]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Vaginitis/Vulvitis [3]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Vaginal Dryness/Pain [3]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Hyperemesis [3]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Urinary tract infection in pregnancy [3]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Dizziness/Vertigo [3]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Rash [3]  0/16 (0.00%)  1/8 (12.50%)  0/14 (0.00%) 
Gas/Bloating [3]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Abdominal Pain [3]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Dyspepsia [3]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Pre-eclampsia [4]  4/16 (25.00%)  1/8 (12.50%)  2/14 (14.29%) 
Gestational Diabetes [4]  3/16 (18.75%)  1/8 (12.50%)  2/14 (14.29%) 
Preterm Delivery [4]  3/16 (18.75%)  0/8 (0.00%)  0/14 (0.00%) 
Premature Rupture of Membranes [4]  3/16 (18.75%)  0/8 (0.00%)  0/14 (0.00%) 
Upper Respiratory Infections [4]  3/16 (18.75%)  0/8 (0.00%)  0/14 (0.00%) 
Placental Abnormalities [4]  1/16 (6.25%)  1/8 (12.50%)  0/14 (0.00%) 
Dental abscess [4]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Dental, other [4]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Other specified disorders of biliary tract [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Breast lump [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Vaginitis/Vulvitis [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Urinary tract infection in pregnancy [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Incompetent cervix [4]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Infection of amniotic cavity [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Pruritus [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Dizziness/Vertigo [4]  0/16 (0.00%)  1/8 (12.50%)  0/14 (0.00%) 
Sleep disturbance [4]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Sleep apnea [4]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Edema localized [4]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Glycosuria [4]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Headache [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Musculoskeletal Pain [4]  0/16 (0.00%)  0/8 (0.00%)  1/14 (7.14%) 
Pregnancy-induced Hypertension [5]  2/16 (12.50%)  0/8 (0.00%)  0/14 (0.00%) 
Pulmonary collapse [5]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Postpartum depression [5]  0/16 (0.00%)  1/8 (12.50%)  0/14 (0.00%) 
Postpartum infection [5]  1/16 (6.25%)  0/8 (0.00%)  0/14 (0.00%) 
Neonatal Jaundice [6]  2/12 (16.67%)  1/5 (20.00%)  4/12 (33.33%) 
Intrauterine growth restriction [6]  1/12 (8.33%)  0/5 (0.00%)  1/12 (8.33%) 
Neonatal infection [6]  0/12 (0.00%)  0/5 (0.00%)  1/12 (8.33%) 
Other complication of infant after delivery [6]  0/12 (0.00%)  0/5 (0.00%)  1/12 (8.33%) 
Psychiatric disorders       
Mood Swings [1]  3/50 (6.00%)  3/49 (6.12%)  3/50 (6.00%) 
Mood Swings [2]  3/44 (6.82%)  3/44 (6.82%)  2/43 (4.65%) 
Reproductive system and breast disorders       
Breast Pain [1]  1/50 (2.00%)  10/49 (20.41%)  6/50 (12.00%) 
Dysmenorrhea [1]  1/50 (2.00%)  8/49 (16.33%)  3/50 (6.00%) 
Abnormal uterine bleeding [1]  0/50 (0.00%)  4/49 (8.16%)  6/50 (12.00%) 
Vaginitis/Vulvitis [1]  1/50 (2.00%)  4/49 (8.16%)  1/50 (2.00%) 
Pelvic Pain [1]  2/50 (4.00%)  3/49 (6.12%)  1/50 (2.00%) 
Pelvic Pain [2]  7/44 (15.91%)  12/44 (27.27%)  13/43 (30.23%) 
Breast Pain [2]  5/44 (11.36%)  7/44 (15.91%)  9/43 (20.93%) 
Hot flushes [2]  4/44 (9.09%)  6/44 (13.64%)  3/43 (6.98%) 
Dysmenorrhea [2]  1/44 (2.27%)  6/44 (13.64%)  1/43 (2.33%) 
Vaginal Dryness/Pain [2]  0/44 (0.00%)  3/44 (6.82%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Infections [1]  8/50 (16.00%)  8/49 (16.33%)  13/50 (26.00%) 
Upper Respiratory Infections [2]  2/44 (4.55%)  5/44 (11.36%)  5/43 (11.63%) 
[1]
Phase I Intervention
[2]
Phase II Ovulation Induction
[3]
Phase III After Conception: First trimester
[4]
Phase III After Conception: Second and Third trimester
[5]
Delivery and Postpartum
[6]
After 20 weeks pregnancy in fetus through neonatal period
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard S. Legro, M.D.
Organization: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Phone: 717-531-8478
EMail: rsl1@psu.edu
Layout table for additonal information
Responsible Party: Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00704912     History of Changes
Other Study ID Numbers: 27184
First Submitted: June 23, 2008
First Posted: June 25, 2008
Results First Submitted: November 13, 2015
Results First Posted: December 17, 2015
Last Update Posted: November 7, 2016