Study: NCT02709005

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 10 affected / 71 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 22 affected / 71 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 23 affected / 71 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 10 affected / 71 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 12 affected / 71 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 9 affected / 71 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 72 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 72 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 72 at risk

Adverse event: Vulvovaginal burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 72 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 72 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Protocol-defined blood chemistry tests were performed on Visit 2 samples (Day 8-15)
Frequency: 1 affected / 72 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: Protocol-defined hematology tests were performed on Visit 2 samples (Day 8-15)
Frequency: 2 affected / 72 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 6 affected / 37 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 5 affected / 37 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 9 affected / 37 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 3 affected / 37 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 8 affected / 37 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited on the memory aid for 5 days after first dose of product and reviewed in the clinic at Visit 2 (Day 8-15)
Frequency: 2 affected / 37 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 37 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 37 at risk

Adverse event: Vulvovaginal burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 37 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 37 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Protocol-defined blood chemistry tests were performed on Visit 2 samples (Day 8-15)
Frequency: 2 affected / 37 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: Protocol-defined hematology tests were performed on Visit 2 samples (Day 8-15)
Frequency: 4 affected / 37 at risk