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Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health)

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Crinone 8% (progesterone gel)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Wyeth
Approval Status: Approved May 1997
Treatment Area: progesterone deficiency

General Information

Crinone has been approved for use as a progesterone supplementation or replacement. It is indicated as a treatment for infertile women with progesterone deficiency. Crinone is used in conjunction with assisted reproductive technology--in-vitro fertilization, ovum donation and stimulated cycles.

It is the first product to deliver progesterone directly to the uterus in a bioadhesive gel. Previously, products available were only administered via intramuscular injections or suppositories.

Clinical Results

In a progesterone replacement clinical study, women requiring progesterone replacement were administered Crinone 8% at a dose of one applicator (90mg) twice daily. Of the 54 women who underwent an embryo transfer and were treated with crinone, 48% achieved a clinical pregnancy, and 31% delivered.

In a progesterone supplement clinical study, women requiring progesterone supplementation were evaluated following an in-vitro fertilization procedure. In this study, patients received one applicator (90mg) of crinone once daily. Of the 139 patients who received an embryo, 26% achieved a clinical pregnancy and 23% delivered.

Side Effects

In women requiring progesterone replacement, the most frequently reported side effects were cramps, breast pain, and headache. In women requiring progestereone supplementation, the most frequently reported side effects were breast enlargement, constipation, somnolence, nausea, and headache.

Women with the following conditions should not use progesterone therapy: a known sensitivity to progesterone, undiagnosed vaginal bleeding, liver dysfunction or disease, known or suspected malignancy of the breast or genital organs, a recent miscarriage with suspected tissue remaining in the uterus, or history of blood clots.