Study: NCT05022212

Adverse event: Abnormal vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 32 at risk

Adverse event: Abnormal vaginal odor
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 32 at risk

Adverse event: external genital irritiation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 32 at risk

Adverse event: external genital swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 32 at risk

Adverse event: genital itching or burning
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 32 at risk

Adverse event: vaginal bleeding other than menstruation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 18 affected / 32 at risk

Adverse event: abdominal pain / cramps
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: abnormal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 32 at risk

Adverse event: urine odor
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pustule
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: eye infection, viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Viral skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: papular pruritic fine erythematous left abdominal flank rash, deemed related to study product, study day 7-12
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Genital ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Notes: clinical diagnosis as genital herpes ulceration
Frequency: 1 affected / 32 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Notes: left axillary
Frequency: 1 affected / 32 at risk

Adverse event: Abnormal vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 13 at risk

Adverse event: genital itching or burning
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 13 at risk

Adverse event: vaginal bleeding other than menstruation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 13 at risk

Adverse event: abdominal pain / cramps
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: pain/ burning with urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk