Study: NCT00290251

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 14 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Hot flush
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Self-reported via calendar
Frequency: 5 affected / 14 at risk

Adverse event: Non-menses Vaginal Bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 6 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 10 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Notes: Self-assessed via calendar
Frequency: 5 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 6 affected / 14 at risk

Adverse event: Decreased appetitie
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Calf or Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 5 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar using write-in option
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed by calendar
Frequency: 4 affected / 14 at risk

Adverse event: Depersonalisation/derealisation disorder
Serious: no
Organ System: General disorders
Notes: Out of body experience
Frequency: 1 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: blood clots with menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: constipaton
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Peripheral coldness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Galactorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: food cravings
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Breast engorgement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: disrupted sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 14 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Hot flush
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Self-reported via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Non-menses Vaginal Bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 7 affected / 14 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 5 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 9 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Notes: Self-assessed via calendar
Frequency: 7 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 8 affected / 14 at risk

Adverse event: Decreased appetitie
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Calf or Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 7 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Leg swelling
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar and write-in option
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed by calendar
Frequency: 2 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 14 at risk

Adverse event: blood clots with menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 14 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Hot flush
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Self-reported via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Non-menses Vaginal Bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 8 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 10 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Notes: Self-assessed via calendar
Frequency: 5 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 6 affected / 14 at risk

Adverse event: Decreased appetitie
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Calf or Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Notes: self-assessed via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed by calendar
Frequency: 2 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: blood clots with menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 14 at risk

Adverse event: Asthenia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 14 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 7 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 9 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Notes: Self-assessed via calendar
Frequency: 7 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 9 affected / 14 at risk

Adverse event: Decreased appetitie
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 5 affected / 14 at risk

Adverse event: Calf or Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 4 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar using write-in option
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed by calendar
Frequency: 3 affected / 14 at risk

Adverse event: blood clots with menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 14 at risk

Adverse event: constipaton
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 14 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Non-menses Vaginal Bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 11 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Notes: Self-assessed via calendar
Frequency: 5 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 10 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Calf or Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed by calendar
Frequency: 2 affected / 14 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 14 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Non-menses Vaginal Bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self-assessed via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 8 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Notes: Self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 6 affected / 14 at risk

Adverse event: Decreased appetitie
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 3 affected / 14 at risk

Adverse event: Calf or Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: self-assessed via calendar
Frequency: 2 affected / 14 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Notes: self-assessed via calendar
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self-assessed by calendar
Frequency: 1 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: blood clots with menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 14 at risk