Study: NCT01617096

Adverse event: Vaginal discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 1313 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 1313 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 16 affected / 1313 at risk

Adverse event: Vulvovaginal pruritus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 1313 at risk

Adverse event: Vulvovaginal discomfort
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 1313 at risk

Adverse event: Cervix erythema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 1313 at risk

Adverse event: Vaginal odour
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1313 at risk

Adverse event: Dyspareunia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1313 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1313 at risk

Adverse event: Pelvic discomfort
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1313 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1313 at risk

Adverse event: Uterine pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Cervical discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Cervix haemorrage uterine
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1313 at risk

Adverse event: Cervix oedema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1313 at risk

Adverse event: Coital bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Vaginal erosion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1313 at risk

Adverse event: Vulvovaginal dryness
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Vulvovaginal pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Genital discomfort
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1313 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1313 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1313 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1313 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1313 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1313 at risk

Adverse event: Cervicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1313 at risk

Adverse event: Vulvovaginitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1313 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1313 at risk

Adverse event: Vulvovaginal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1313 at risk

Adverse event: Application site discomfort
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1313 at risk

Adverse event: Application site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Pollakiurua
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1313 at risk

Adverse event: Bladder pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Micturition urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Strangury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Vulvovaginal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1313 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1313 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 723 affected / 1313 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 259 affected / 1313 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 179 affected / 1313 at risk

Adverse event: Menometrorrhagia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 160 affected / 1313 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 128 affected / 1313 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 127 affected / 1313 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 42 affected / 1313 at risk

Adverse event: Vulval ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 29 affected / 1313 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 1313 at risk

Adverse event: Genitourinary chlamydia infection
Serious: no
Organ System: Infections and infestations
Frequency: 269 affected / 1313 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 223 affected / 1313 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 168 affected / 1313 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 149 affected / 1313 at risk

Adverse event: Genitourinary tract gonococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 143 affected / 1313 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 140 affected / 1313 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 148 affected / 1313 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 1313 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 1313 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 1313 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 1313 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 1313 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 1313 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 1313 at risk

Adverse event: Pelvic inflammatory disease
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 1313 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 147 affected / 1313 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 144 affected / 1313 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 125 affected / 1313 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 118 affected / 1313 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 1313 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 173 affected / 1313 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 1313 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 79 affected / 1313 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 1313 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 1313 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 1313 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 1313 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 34 affected / 1313 at risk

Adverse event: Vaginal discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 1316 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 1316 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 1316 at risk

Adverse event: Vulvovaginal pruritus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 1316 at risk

Adverse event: Vulvovaginal discomfort
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Cervix erythema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Vaginal odour
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 1316 at risk

Adverse event: Dyspareunia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Pelvic discomfort
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Uterine pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Cervical discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Cervix haemorrage uterine
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Coital bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vulvovaginal dryness
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vulvovaginal pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pruritius genital
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Uterine cervical pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Uterine cervix ulcer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vulvovaginal rash
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 1316 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 1316 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 1316 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Cervicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1316 at risk

Adverse event: Vulvovaginitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1316 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1316 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Application site discomfort
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Application site pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Suprapubic pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pollakiurua
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Urinary hesitation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Abnormal loss of weight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 732 affected / 1316 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 242 affected / 1316 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 174 affected / 1316 at risk

Adverse event: Menometrorrhagia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 148 affected / 1316 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 135 affected / 1316 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 123 affected / 1316 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 46 affected / 1316 at risk

Adverse event: Vulval ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 35 affected / 1316 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 1316 at risk

Adverse event: Genitourinary chlamydia infection
Serious: no
Organ System: Infections and infestations
Frequency: 274 affected / 1316 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 281 affected / 1316 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 157 affected / 1316 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 158 affected / 1316 at risk

Adverse event: Genitourinary tract gonococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 160 affected / 1316 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 139 affected / 1316 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 127 affected / 1316 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 1316 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 1316 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 1316 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 1316 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 1316 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 1316 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 1316 at risk

Adverse event: Pelvic inflammatory disease
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 1316 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 160 affected / 1316 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 145 affected / 1316 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 143 affected / 1316 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 146 affected / 1316 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 1316 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 175 affected / 1316 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 1316 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 95 affected / 1316 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 1316 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 1316 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 1316 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 1316 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 1316 at risk