progesterone vaginal gel (Crinone, Endometrin)

• Intravaginal progesterone gel is used for supplementing or replacing progesterone in infertile women with progesterone deficiency who are receiving treatment utilizing assisted reproductive technology (ART).
  Progesterone intravaginal gel is also used for the treatment of secondary amenorrhea (absence of menses).
• Progesterone is a female hormone and is the principal progestational hormone. Progestational hormones prepare the uterus (the womb) to receive and sustain the fertilized egg. Progesterone promotes the development of the mammary glands, causes changes in the endometrium, which lines the uterus, relaxes uterine smooth muscles, blocks ovulation within the ovaries, and maintains pregnancy.
• The FDA approved progesterone intravaginal gel in July 1997.

What brand names are available for progesterone gel?

Crinone, Endometrin

Is progesterone gel available as a generic drug?

No

Do I need a prescription for progesterone gel?

Yes

Crinone (progesterone) gel is a bioadhesive vaginal gel contained in single-use, one-piece polyethylene vaginal applicators. Crinone is indicated as treatment for infertile women with progesterone deficiency and women with secondary amenorrhea. Crinone is available as a generic drug. Common side effects of Crinone include:

• bloating,
• stomach pain,
• dizziness,
• drowsiness,
• tired feeling,
• headache,
• nausea,
• vomiting,
• stomach cramps,
• diarrhea,
• constipation,
• pain in your vaginal or rectal area,
• pain during intercourse,
• loss of interest in sex,
• breast swelling or tenderness,
• joint or muscle pain,
• increased night-time urination,
• vaginal discharge,
• vaginal burning, and
• vaginal itching.

Tell your doctor if you have serious side effects of Crinone including:

• sudden headache, numbness or weakness (especially on one side of the body):
• shortness of breath, or problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder;
• pain or swelling in one or both legs;
• stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• fever, chills, body aches, flu symptoms;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

• For ART, the recommended dose of the 8% gel is 90 mg once daily in women who require progesterone supplementation, and 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.
• For the treatment of secondary amenorrhea, the 4% gel is administered vaginally every other day for six doses. Women who do not respond should receive the 8% gel.

• There are no drug interactions listed for progesterone intravaginal gel.

• Progesterone intravaginal gel has been used to support embryo implantation and to maintain pregnancies as part of an ART treatment regimen. Progestins are secreted in breast milk.

What preparations of progesterone gel are available?

• Intravaginal gel: 4 and 8%;
• Intravaginal Insert: 100 mg

How should I keep progesterone gel stored?

• Progesterone intravaginal gel should be stored at room temperature, 20 C to 25 C (68 F to 77 F)