Trial Outcomes & Findings for Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women (NCT NCT03366077)
NCT ID: NCT03366077
Last Updated: 2025-09-15
Results Overview
Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
6 months
Results posted on
2025-09-15
Participant Flow
One of the participants randomised to the placebo group did not start the intervention, therefore it is a discrepancy between the planned and actual number of started participants.
Participant milestones
| Measure |
Active
Probiotics
|
Placebo
Placebo control group
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
|
Overall Study
COMPLETED
|
61
|
65
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women
Baseline characteristics by cohort
| Measure |
Active
n=65 Participants
Probiotics
|
Placebo
n=67 Participants
Placebo Control Group
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
30.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
30.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
65 participants
n=5 Participants
|
67 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
Height
|
166.4 cm
STANDARD_DEVIATION 5.4 • n=5 Participants
|
167.2 cm
STANDARD_DEVIATION 6.5 • n=7 Participants
|
166.8 cm
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
weight
|
65.7 kg
STANDARD_DEVIATION 10.9 • n=5 Participants
|
66.2 kg
STANDARD_DEVIATION 12.7 • n=7 Participants
|
65.9 kg
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Body Mass Index
|
23.7 kg/m^2
STANDARD_DEVIATION 3.7 • n=5 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsMean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo.
Outcome measures
| Measure |
Active
n=65 Participants
Sachet 1 - instant drink: Xylitol, Monosodium Citrate, Cranberry Aroma, Cranberry Extract, Grape-skin Extract, Xanthan Gum, Acesulfame Potassium and Zinc Gluconate
Sachet 2 - probiotic mix: Maltodextrin, L. reuteri DSM 16666 and L. reuteri DSM 17938
|
Placebo
n=67 Participants
Sachet 1 - instant drink: Xylitol, Monosodium Citrate, Cranberry Aroma, Grape-skin Extract, Xanthan Gum and Acesulfame Potassium
Sachet 2 - maltodextrin: Maltodextrin
|
|---|---|---|
|
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI.
|
1.2 Number of unique UTIs during study
Standard Deviation 1.4
|
1.3 Number of unique UTIs during study
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 monthMean number of confirmed UTIs during the three months intervention period, as compared to placebo. Mean number of confirmed UTIs during the three months follow-up period, as compared to placebo. Mean time from start of intervention to first relapse of UTI, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during three months from start of intervention, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during six months from start of intervention, as compared to placebo. Occurrence and frequency of Adverse Events (AEs).
Outcome measures
Outcome data not reported
Adverse Events
Active
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=70 participants at risk
L reuteri
Probiotic: Probiotic
|
Placebo
n=69 participants at risk
Placebo
Probiotic: Probiotic
|
|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous miscarriage
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Endometritis
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
Other adverse events
| Measure |
Active
n=70 participants at risk
L reuteri
Probiotic: Probiotic
|
Placebo
n=69 participants at risk
Placebo
Probiotic: Probiotic
|
|---|---|---|
|
Nervous system disorders
Migraine
|
2.9%
2/70 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
General disorders
Pyrexia
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
4.3%
3/69 • Number of events 4 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Nasopharyngitis
|
17.1%
12/70 • Number of events 15 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
26.1%
18/69 • Number of events 21 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Eye disorders
Conjunctivitis allergic
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Immune system disorders
Dust Allergy
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Nervous system disorders
Headache
|
8.6%
6/70 • Number of events 7 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
4.3%
3/69 • Number of events 3 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Immune system disorders
Seasonal allergy
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Renal and urinary disorders
Urine odour abnormal
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
General disorders
Worsening post surgical pain
|
1.4%
1/70 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
2/70 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Gastrointestinal disorders
abdominal pain upper
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
vulvovaginal candidiasis
|
2.9%
2/70 • Number of events 3 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
2.9%
2/69 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Influenza
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Gastrointestinal disorders
abdominal distension
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Injury, poisoning and procedural complications
radius fracture
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.9%
2/70 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
2.9%
2/69 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Tonsillitis
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Toe infection
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Injury, poisoning and procedural complications
head injury
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
0.00%
0/69 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.4%
1/70 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
2.9%
2/69 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
2.9%
2/69 • Number of events 2 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Vascular disorders
Hypertension
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Vaginosis bacterial
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Borrelia
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Endocrine disorders
blood thyroid stimulating hormone increased
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Musculoskeletal and connective tissue disorders
musculosceletal pain
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Skin infection
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Reproductive system and breast disorders
abortion spontaneous
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Reproductive system and breast disorders
dysfunctional uterine bleeding
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Reproductive system and breast disorders
Endometritis
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
|
Infections and infestations
Urethritis
|
0.00%
0/70 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • 6 months
In this study, the IP is a food supplement and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place