Trial Outcomes & Findings for A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding (NCT NCT01280981)
NCT ID: NCT01280981
Last Updated: 2011-07-26
Results Overview
Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
288 participants
Primary outcome timeframe
Day 1 to up to Month 9
Results posted on
2011-07-26
Participant Flow
Participants who completed double-blind therapy in either study XP12B-MR-301 (NCT00401193) or XP12B-MR-303 (NCT00386308) could participate in this trial.
Participant milestones
| Measure |
Tranexamic Acid
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Overall Study
STARTED
|
288
|
|
Overall Study
Intent to Treat (ITT) Population
|
260
|
|
Overall Study
COMPLETED
|
196
|
|
Overall Study
NOT COMPLETED
|
92
|
Reasons for withdrawal
| Measure |
Tranexamic Acid
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Lack of Efficacy
|
13
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Irregular or discontinued menses
|
3
|
|
Overall Study
Failed to return
|
45
|
|
Overall Study
Non-compliance with protocol
|
3
|
|
Overall Study
Withdrawal of consent
|
3
|
|
Overall Study
Elective surgery
|
2
|
|
Overall Study
Study site closure
|
1
|
Baseline Characteristics
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=288 Participants
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
288 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
288 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 1 to up to Month 9Population: Intent to treat population (ITT)
Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.
Outcome measures
| Measure |
Tranexamic Acid
n=260 Participants
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Any treatment-emergent AE
|
218 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Definitely related AE
|
1 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Probably related AE
|
3 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Possibly related AE
|
60 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Serious AE
|
5 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Life-threatening AE
|
2 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Died
|
0 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
AE led to withdrawal from study
|
6 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Thrombotic or thromboembolic AE
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to up to Month 9Population: Intent to treat population
Participants with abnormal gynecological examination findings based on endometrial biopsies and transvaginal ultraonogrphy (TVU) are summarized. Clinically significant results from the endometrial biopsies are results that are not benign. Abnormalities found during transvaginal ultrasonography (TVU) are detailed in the AE listings. Please refer to AE listings.
Outcome measures
| Measure |
Tranexamic Acid
n=260 Participants
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Participants With Abnormal Gynecological Examinations
Significant results from endometrial biopsies
|
0 participants
|
|
Participants With Abnormal Gynecological Examinations
Abnormalities noted on TVU
|
3 participants
|
|
Participants With Abnormal Gynecological Examinations
Discontinued due to failed physical exam
|
0 participants
|
SECONDARY outcome
Timeframe: approximately week 36Population: Intent to treat population of participants with week 36 blood pressure data.
Mean systolic and diastolic blood pressure measurements taken at week 36
Outcome measures
| Measure |
Tranexamic Acid
n=200 Participants
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Mean Blood Pressure Measurements at Week 36
Systolic blood pressure
|
118.94 mmHg
Standard Deviation 14.272
|
|
Mean Blood Pressure Measurements at Week 36
Diastolic blood pressure
|
75.09 mmHg
Standard Deviation 10.167
|
SECONDARY outcome
Timeframe: Day 1 to up to Month 9Population: Intent to treat population
Participants whose laboratory examinations (hematology, blood chemistry and urinalysis) were considered by the investigator to be treatment emergent adverse experiences (TEAE) and related to treatment. Also indicated is whether the TEAE lab parameter caused the participant to discontinue from the study.
Outcome measures
| Measure |
Tranexamic Acid
n=260 Participants
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Hematology TEAE related to study drug
|
1 participants
|
|
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Discontinued due to hematology TEAE
|
1 participants
|
|
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Blood chemistry TEAE related to study drug
|
1 participants
|
|
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Discontinued due to blood chemistry TEAE
|
0 participants
|
|
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Urinalysis TEAE related to study drug
|
2 participants
|
|
Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment
Discontinued due to urinalysis TEAE
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Month 9Population: Intent to treat participants who had ophthalmic exams.
Mean intraocular pressure at month 9 or the early termination visit.
Outcome measures
| Measure |
Tranexamic Acid
n=199 Participants
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Mean Intraocular Pressure at Month 9
Right eye
|
15.4 mmHg
Standard Deviation 2.866
|
|
Mean Intraocular Pressure at Month 9
Left eye
|
15.3 mmHg
Standard Deviation 2.797
|
SECONDARY outcome
Timeframe: Month 9Population: Intent to treat participants who had an electrocardiogram (ECG) at month 9
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization
Outcome measures
| Measure |
Tranexamic Acid
n=193 Participants
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9
|
412.3 milliseconds
Standard Deviation 15.896
|
Adverse Events
Tranexamic Acid
Serious events: 5 serious events
Other events: 218 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tranexamic Acid
n=260 participants at risk
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Investigations
Blood glucose decreased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Brain stem infarction
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Intracranial aneurysm
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
Other adverse events
| Measure |
Tranexamic Acid
n=260 participants at risk
Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
10/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Ear and labyrinth disorders
Ear congestion
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Endocrine disorders
Hypothyroidism
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Chalazion
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Conjunctivitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Corneal pigmentation
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Dry eye
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Eye discharge
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Eye irritation
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Ocular hypertension
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Retinal artery stenosis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Retinal pigmentation
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Eye disorders
Vision blurred
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.8%
15/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
12/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
15/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Anal polyp
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Chapped lips
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Constipation
|
3.5%
9/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
19/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Dry mouth
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
9/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Flatulence
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Food poisoning
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Gastritis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Gingival pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Gingival swelling
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Lip blister
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Loose stools
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Nausea
|
6.5%
17/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Oesophagitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Tongue disorder
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Toothache
|
4.2%
11/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
6/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Chest discomfort
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Chest pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Chills
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Cyst
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Fatigue
|
5.4%
14/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Influenza like illness
|
5.8%
15/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Localized oedema
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Oedema
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Pyrexia
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
General disorders
Swelling
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Hepatobiliary disorders
Cholecystitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Immune system disorders
Multiple allergies
|
5.0%
13/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Immune system disorders
Seasonal allergies
|
3.5%
9/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Acute sinusitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Bronchitis
|
1.9%
5/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Cystitis
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Ear infection
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Herpes simplex
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Herpes zoster
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Influenza
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Kidney infection
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Laryngitis
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Onychomycosis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Otitis media
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Pneumonia
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Recurring skin boils
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Rhinitis
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Salpingitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Sinusitis
|
8.5%
22/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Tonsillitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Tooth abscess
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Tooth infection
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
9/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Urinary tract infection
|
3.1%
8/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Vaginal candidiasis
|
1.9%
5/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.9%
31/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Back injury
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
2.7%
7/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Aspartate aminotransferase increased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Biopsy breast
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Blood cholesterol increased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Blood glucose increased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Blood triglycerides increased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Blood urine present
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Cardiac murmur
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Faecal occult blood
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Haematocrit decreased
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Haemoglobin decreased
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Human papilloma virus serology test negative
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Human papilloma virus serology test positive
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Lipids increased
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Lymph node palpable
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Mean cell haemoglobin decreased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Monocyte count decreased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Red blood cell count decreased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Serum ferritin decreased
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Smear cervix abnormal
|
2.7%
7/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Thyroxine increased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Ultrasound uterus
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Urinary occult blood positive
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Investigations
Weight increased
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
15/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.1%
60/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
4.2%
11/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
15/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
7/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
13/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
20/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Dizziness
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Headache
|
43.8%
114/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Migraine
|
7.7%
20/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Paraesthesia
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Restless leg syndrome
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Sedation
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Sinus headache
|
6.5%
17/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Nervous system disorders
Tension headache
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Anxiety
|
2.7%
7/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Depressed mood
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Depression
|
3.5%
9/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Insomnia
|
4.2%
11/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Irritability
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Mood swings
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Psychiatric disorders
Stress symptoms
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Renal and urinary disorders
Bladder pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Renal and urinary disorders
Dysuria
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Renal and urinary disorders
Polyuria
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Breast cyst
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Breast discharge
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Breast mass
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Breast pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.9%
5/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.9%
5/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Nipple pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Paraesthesia of genital female
|
3.1%
8/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Pruritus genital
|
2.3%
6/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Uterine leiomyoma
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Uterine pain
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.7%
7/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
4/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
12/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.5%
9/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.2%
16/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.3%
6/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.77%
2/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Lichenification
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Surgical and medical procedures
Benign breast lump removal
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Surgical and medical procedures
Meniscus operation
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Surgical and medical procedures
Surgery
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Vascular disorders
Flushing
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Vascular disorders
Hypertension
|
1.2%
3/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Vascular disorders
Hypotension
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
|
Vascular disorders
Varicose vein
|
0.38%
1/260 • Treatment-emergent AEs: day 1 up to month 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER