Study: NCT00074802

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: 24 year old female reported heavy menstrual bleeding. It was determined that the bleeding was likely related to polycystic ovarian syndrome. Bleeding returned to normal levels after initiation of hormone treatment. SAE unrelated to study meds.
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 29 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 10 affected / 29 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 11 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 12 affected / 29 at risk

Adverse event: Photophobia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 29 at risk

Adverse event: Bradycardia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 13 affected / 29 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Parathesias
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: General disorders
Frequency: 16 affected / 29 at risk

Adverse event: Anorgasmia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 29 at risk

Adverse event: Impaired Coordination
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 29 at risk

Adverse event: Nervousness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 29 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 19 affected / 29 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Dermatitis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Urinary Congestion
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 7 affected / 29 at risk

Adverse event: Muscle rigidity
Serious: no
Organ System: General disorders
Frequency: 7 affected / 29 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 16 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 32 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

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

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Photophobia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

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

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

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

Adverse event: Parathesias
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: General disorders
Frequency: 18 affected / 32 at risk

Adverse event: Anorgasmia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 32 at risk

Adverse event: Impaired Coordination
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 32 at risk

Adverse event: Nervousness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 18 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Dermatitis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Urinary Congestion
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Muscle rigidity
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 17 affected / 32 at risk