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)

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)

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

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 -Disonters-conjunctivitis

Read the Crinone (progesterone gel) Side Effects Center for a complete guide to possible side effects »

No drug interactions have been assessed with Crinone.

Last reviewed on RxList: 1/3/2012
This monograph has been modified to include the generic and brand name in many instances.