ADVERSE REACTIONS
ASSISTED REPRODUCTIVE TECHNOLOGY
In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone® 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3.
TABLE 3
Treatment-Emergent Adverse Events
in >/=5% of Women Receiving Crinone® 8%
Twice Daily
Study COL1620-007US (n=61)
|
Body as a Whole
|
|
Bloating
|
7%
|
|
Cramps NOS
|
15%
|
|
Pain
|
8%
|
|
Central and Peripheral Nervous System
|
|
Dizziness
|
5%
|
|
Headache
|
13%
|
|
Gastro-Intestinal System
|
|
Nausea
|
7%
|
|
Reproductive, Female
|
|
Breast Pain
|
13%
|
|
Moniliasis Genital
|
5%
|
|
Vaginal Discharge
|
7%
|
|
Skin and Appendages
|
|
Pruritus Genital
|
5%
|
|
In a second clinical study of 139 women using Crinone® 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in >/=5% of the women are shown in Table 4.
TABLE 4
Treatment-Emergent Adverse Events
in >/=5% of Women Receiving Crinone® 8%
Once Daily
Study COL1620-F01 (n=139)
|
Body as a Whole
|
|
|
Abdominal Pain
|
12%
|
|
Perineal Pain Female
|
17%
|
|
Central and Periphal Nervous System
|
|
Headache
|
17%
|
|
Gastro-Intestinal System
|
|
Constipation
|
27%
|
|
Diarrhea
|
8%
|
|
Nausea
|
22%
|
|
Vomiting
|
5%
|
|
Musculo-Skeletal System
|
|
Arthralgia
|
8%
|
|
Psychiatric
|
|
Depression
|
11%
|
|
Libido Decreased
|
10%
|
|
Nervousness
|
16%
|
|
Somnolence
|
27%
|
|
Reproductive, Female
|
|
Breast Enlargement
|
40%
|
|
Dyspareunia
|
6%
|
|
Urinary System
|
|
Nocturia
|
13%
|
|
SECONDARY AMENORRHEA
In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone® 4% or 8% every other day for six doses. Treatment emergent adverse events during estrogen and Crinone® treatment that occurred in 5% or more of women are shown in Table 5.
TABLE 5
Treatment Emergent Adverse Events in >/=5% of Women
Receiving Estrogen Treatment and Crinone® Every
Other Day
Studies COL1620-004US, COL1620-005US,
COL1620-009US
|
|
Estrogen
+Crinone® 4%
n=62
|
Estrogen
+Crinone® 8%
n=65
|
|
Body as a Whole
|
|
Abdominal Pain
|
3 (5%) |
6 (9%) |
|
Appetite Increased
|
3 (5%) |
5 (8%) |
|
Bloating
|
8 (13%) |
8 (12%) |
|
Cramps NOS
|
12 (19%) |
17 (26%) |
|
Fatigue
|
13 (21%) |
14 (22%) |
|
Central and Peripheral Nervous System
|
|
Headache
|
12 (19%) |
10 (15%) |
|
Gastro-Intestinal System
|
|
Nausea
|
5 (8%) |
4 (6%) |
|
Musculo-Skeletal System
|
|
Back Pain
|
5 (8%) |
2 (3%) |
|
Myalgia
|
5 (8%) |
0 (0%) |
|
Psychiatric
|
|
Depression
|
12 (19%) |
10 (15%) |
|
Emotional Lability
|
14 (23%) |
14 (22%) |
|
Sleep Disorder
|
11 (18%) |
12 (18%) |
|
Reproductive, Female
|
|
Vaginal Discharge
|
7 (11%) |
2 (3%) |
|
Resistance Mechanism
|
Upper Respiratory
Tract Infection
|
3 (5%) |
5 (8%) |
|
Skin and Appendages
|
|
Pruritis genital
|
1 (2%) |
4 (6%) |
|
Additional adverse events reported in women at a frequency <5% in Crinone® ART and secondary amenorrhea studies and not listed in the tables above include: Autonomic Nervous System- mouth dry, sweating increased
Body as a Whole- abnormal crying, allergic reaction, allergy, appetite decreased, asthenia, edema, face edema, fever, hot flushes, influenza-like symptoms, water retention, xerophthalmia
Cardiovascular, General- syncope
Central and Peripheral Nervous System- migraine, tremor
Gastro-Intestinal- dyspepsia, eructation, flatulence, gastritis, toothache
Metabolic and Nutritional- thirst
Musculo-Skeletal System- cramps legs, leg pain, skeletal pain
Neoplasm- benign cyst
Platelet, Bleeding & Clotting- purpura
Psychiatric- aggressive reactions, forgetfulness, insomnia
Red Blood Cell- anemia
Reproductive, Female- dysmenorrhea, premenstrual tension, vaginal dryness
Resistance Mechanism- infection, pharyngitis, sinusitis, urinary tract infection
Respiratory System- asthma, dyspnea, hyperventilation, rhinitis
Skin and Appendages- acne, pruritus, rash, seborrhea, skin discoloration, skin disorder, urticaria
Urinary System- cystitis, dysuria, micturition frequency
Vision Disorders- conjunctivitis
|
