Study: NCT00653159

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a sensation of marked discomfort in the abdominal region.
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.
Frequency: 2 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: A disorder characterized by elevation of the body's temperature above the upper limit of normal.
Frequency: 2 affected / 11 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Notes: Bacterial vaginosis is the name of a condition in women where the normal balance of bacteria in the vagina is disrupted and replaced by an overgrowth of certain bacteria. It is sometimes accompanied by discharge, odor, pain, itching, or burning.
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra
Frequency: 1 affected / 11 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: A finding characterized by an increase in overall body weight; for pediatrics, greater than the baseline growth curve.
Frequency: 1 affected / 11 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve
Frequency: 1 affected / 11 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by a decrease in sexual desire.
Frequency: 1 affected / 11 at risk

Adverse event: Psychiatric disorders - Other (Mood Swings)
Serious: no
Organ System: Psychiatric disorders
Notes: A mood swing is an extreme or rapid change in mood.
Frequency: 1 affected / 11 at risk

Adverse event: Breast swelling
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Swelling and tenderness of the breasts
Frequency: 1 affected / 11 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by irregular cycle or duration of menses
Frequency: 1 affected / 11 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by abnormally heavy vaginal bleeding during menses.
Frequency: 5 affected / 11 at risk

Adverse event: Menstrual pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain during menses
Frequency: 11 affected / 11 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Disorder characterized by reduction in the amt of hemoglobin in 100 ml of blood. Signs/symptoms may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.
Frequency: 2 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a queasy sensation and/or the urge to vomit.
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: A disorder characterized by elevation of the body's temperature above the upper limit of normal.
Frequency: 3 affected / 12 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Notes: Pain in the leg.
Frequency: 1 affected / 12 at risk

Adverse event: Abscess/infection of Bartholin's gland
Serious: no
Organ System: Infections and infestations
Notes: Abscess/infection of Bartholin's gland
Frequency: 1 affected / 12 at risk

Adverse event: Trichomoniasis
Serious: no
Organ System: Infections and infestations
Notes: Trichomoniasis (or "trich") is a very common sexually transmitted disease (STD) that is caused by infection with a protozoan parasite called Trichomonas vaginalis.
Frequency: 1 affected / 12 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: A finding characterized by an increase in overall body weight; for pediatrics, greater than the baseline growth curve.
Frequency: 2 affected / 12 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve
Frequency: 1 affected / 12 at risk

Adverse event: Psychiatric disorders - Other (Mood Swings)
Serious: no
Organ System: Psychiatric disorders
Notes: A mood swing is an extreme or rapid change in mood.
Frequency: 2 affected / 12 at risk

Adverse event: Breast swelling
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Swelling and tenderness of the breasts
Frequency: 2 affected / 12 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by irregular cycle or duration of menses
Frequency: 1 affected / 12 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by abnormally heavy vaginal bleeding during menses.
Frequency: 5 affected / 12 at risk

Adverse event: Menstrual pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain during menses
Frequency: 5 affected / 12 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.
Frequency: 3 affected / 12 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge
Frequency: 1 affected / 12 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Acne is a common human skin disease, characterized by areas of skin with seborrhea (scaly red skin), comedones (blackheads and whiteheads), papules (pinheads), pustules (pimples), nodules (large papules) and possibly scarring.
Frequency: 3 affected / 12 at risk