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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 Peripheral Nervous System
  Headache 17%
Gastro-Intestinal System  
  Constipation 27%
  Diarrhea 8%
  Nausea 22%
  Vomiting   5%
  Musculo-Skeletal System 8%
  Arthralgia 8%
Psychiatric
  Depression 11%
  Libido Decreased 10%
  Nervousness 16%
  Somnolence 27%
Reproductive, Female
  Breast Enlargement 40%
Dyspareunia
  Urinary System 6%
  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
  Pruritus Genital 1 (2%) 4 (6%)