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Uses

Amenorrhea

Treatment of secondary amenorrhea.

Assisted Reproductive Technology

Used to support embryo implantation and early pregnancy as part of assisted reproductive technology (ART) treatment of infertile women.

Prevention of Endometrial Changes Associated with Estrogens

Reduction of the incidence of endometrial hyperplasia and the attendant risk of endometrial carcinoma in postmenopausal women receiving estrogen replacement therapy.

Uterine Bleeding

Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology such as fibroids or uterine cancer.

Dosage and Administration

Administration

Administer orally, parenterally, or intravaginally as a gel or insert.

Oral Administration

Administer once daily at bedtime. Administration at bedtime may alleviate some adverse effects (e.g., dizziness, blurred vision).

If difficulty swallowing the capsule is experienced, administer in an upright position with adequate amounts of fluid (e.g., a glass of water).

IM Administration

Administer by IM injection.

Vaginal Administration

Progesterone vaginal gel (Crinone^®): Administer intravaginally every other day, every day, or twice daily. Do not administer concurrently with other vaginal preparations. If therapy with another agent administered intravaginally is needed, administer the other agent 6 hours before or after progesterone vaginal gel.

Progesterone vaginal insert (Endometrin^®): Administer intravaginally 2–3 times daily. Concomitant use with other preparations administered intravaginally is not recommended.

Dosage

Individualize dosage according to the condition being treated and therapeutic response of the patient.

Progesterone 4% vaginal gel (Crinone^®): Each prefilled applicator delivers approximately 1.125 g of gel (45 mg of progesterone).

Progesterone 8% vaginal gel (Crinone^®): Each prefilled applicator delivers approximately 1.125 g of gel (90 mg of progesterone).

Progesterone vaginal insert (Endometrin^®): Appropriate dose for women ≥35 years of age not established.

Adults

Amenorrhea

Oral

400 mg daily for 10 days.

IM

5–10 mg daily for 6–8 consecutive days.

Withdrawal bleeding usually occurs within 48–72 hours after discontinuing therapy. Spontaneous normal cycles may occur in some patients after a single course of therapy.

Vaginal

Progesterone 4% vaginal gel (Crinone^®): Administer contents of one prefilled applicator every other day for a total of 6 doses.

For patients who do not respond to the 4% gel, administer the contents of one prefilled applicator of progesterone 8% vaginal gel (Crinone^®) every other day for a total of 6 doses. Women who require the higher dose should receive Crinone^® 8% vaginal gel; increasing the volume of the 4% gel will not achieve the same progesterone concentrations as the 8% gel.

Assisted Reproductive Technology

Progesterone Supplementation/Replacement

Vaginal

Progesterone 8% vaginal gel (Crinone^®): For women who require progesterone supplementation, administer contents of one prefilled applicator once daily. If pregnancy occurs, continue until placenta autonomy is achieved, up to 10–12 weeks.

Progesterone 8% vaginal gel (Crinone^®): For women who require progesterone replacement, administer contents of one prefilled applicator twice daily. If pregnancy occurs, continue until placenta autonomy is achieved, up to 10–12 weeks.

Progesterone vaginal insert (Endometrin^®): One insert 2–3 times daily. Start at oocyte retrieval; continue for up to 10 weeks.

Prevention of Endometrial Changes Associated with Estrogens

Oral

200 mg daily for 12 continuous days per 28-day cycle.

Uterine Bleeding

IM

5–10 mg daily for 6 days. When used concomitantly with estrogen therapy, initiate progesterone therapy after 2 weeks of estrogen therapy. Discontinue progesterone if menses occurs during the series of injections.