ADVERSE REACTIONS
Assisted Reproductive Technology
In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Prochieve® 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 Prochieve® 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 Prochieve® 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 Prochieve® 8% Once Daily Study COL1620-F01 (n=139)
Body as a Whole |
Abdominal Pain |
12% |
Perineal Pain Female |
17% |
Central and Peripheral 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 Prochieve® 4% or 8% every other day for six doses. Treatment emergent adverse events during estrogen and Prochieve® 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 Prochieve® Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US
|
Estrogen + Prochieve® 4% n=62 |
Estrogen + Prochieve® 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 |
Pruitis genital |
1 (2%) |
4 (6%) |
Additional adverse events reported in women at a frequency <5% in Prochieve® 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, pruritis, rash, seborrhea, skin discoloration, skin disorder, urticaria
Urinary System–cystitis, dysuria, micturition frequency
Vision Disorders–conjunctivitis
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