endometrin-packaging

Discover how ENDOMETRIN® (progesterone) Vaginal Insert can move you forward

Prescribing Information

stork-endometrin

ENDOMETRIN is a vaginal insert that contains the hormone progesterone. ENDOMETRIN is for women who need extra progesterone while undergoing treatment in an assisted reproductive technology (ART) cycle.

Progesterone is one of the hormones essential for helping you to become and to stay pregnant. If you are undergoing ART treatment, your doctor may prescribe ENDOMETRIN to provide the progesterone your body needs.

In a US IVF trial with more than 1200 patients, ENDOMETRIN was proven effective.

Each ENDOMETRIN insert supplies 100 mg of progesterone and comes with its own single-use disposable applicator for sterile insertion into the vagina, 2 or 3 times a day, for up to 10 weeks, as your doctor prescribes.

ENDOMETRIN can be inserted while you are standing, sitting, or lying on your back with your knees bent.

Expand All

What is ENDOMETRIN?

ENDOMETRIN is a vaginal insert that contains the hormone progesterone. ENDOMETRIN is for women who need extra progesterone while undergoing treatment in an ART cycle.

Progesterone is one of the hormones essential for helping you to become and to stay pregnant. If you are undergoing ART treatment, your doctor may prescribe ENDOMETRIN to provide the progesterone your body needs.

What does ENDOMETRIN do?

After egg retrieval, ENDOMETRIN may be given to help prepare the uterine lining for embryo implantation and early pregnancy. If you are undergoing ART treatment, your doctor may prescribe ENDOMETRIN to provide progesterone support.

How should I use ENDOMETRIN?

Use ENDOMETRIN exactly as prescribed. The usual dose is 1 insert placed in your vagina 2 to 3 times a day for up to a total of 10 weeks, unless your healthcare provider advises otherwise. Place an ENDOMETRIN insert in your vagina with the disposable applicator provided. Do not use other vaginal products when using ENDOMETRIN.

Who should not use ENDOMETRIN?

Do not use ENDOMETRIN if you:

  • Are allergic to anything in ENDOMETRIN. See the full Prescribing Information for a complete list of ingredients
  • Have unusual vaginal bleeding that has not been evaluated by a doctor
  • Currently have or have had liver problems
  • Have or have had blood clots in the legs, lungs, eyes, or elsewhere in your body

How is ENDOMETRIN supplied?

ENDOMETRIN comes in 100 mg inserts of micronized progesterone. Each ENDOMETRIN insert comes with its own individually wrapped, disposable, polyethylene applicator.

How should I store ENDOMETRIN?

ENDOMETRIN may be stored at room temperature and is good until the printed expiration date.

What are the most common side effects?

Common side effects seen with ART and Endometrin included pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome). Other reported side effects included abdominal bloating, headache, urinary infections, uterine cramping, constipation, vomiting, tiredness, and vaginal bleeding. Vaginal products with progesterone may also cause vaginal irritation, burning and discharge.

These are not all the possible side effects of ENDOMETRIN. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Click here to review Important Safety Information and also full Prescribing Information, including Patient Information.

Have clinical studies been conducted to demonstrate the effectiveness of ENDOMETRIN?

Yes, ENDOMETRIN was shown to be effective in a large published IVF clinical trial in the United States with 1211 patients. For details, please see full Prescribing Information.
IMPORTANT SAFETY INFORMATION
Please see Full Prescribing Information
Please see
Important Safety Information
and full Prescribing Information
IMPORTANT SAFETY INFORMATION

ENDOMETRIN® (progesterone)

ENDOMETRIN® (progesterone) is a vaginal insert that contains the hormone progesterone, one of the hormones essential for helping you to become and to stay pregnant. ENDOMETRIN is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.

Important Safety Information

Do not use ENDOMETRIN if you:

  • Are allergic to anything in ENDOMETRIN
  • Have unusual vaginal bleeding that has not been evaluated by a doctor
  • Currently have or have had liver problems
  • Have or have had blood clots in the legs, lung, eyes, or elsewhere in your body

Common side effects seen with ART and ENDOMETRIN include pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome). Other reported side effects include abdominal bloating, headache, urinary infections, uterine cramping, constipation, vomiting, tiredness and vaginal bleeding. Vaginal products with progesterone may also cause vaginal irritation, burning and discharge.

Progesterone can increase your chance of getting blood clots. Blood clots can be serious and lead to death. Serious blood clots include those in the : legs, lungs, eyes, heart, and brain.

Call your doctor and get medical help right away if you have; Persistent lower leg pain, sudden shortness of breath, coughing up blood, sudden blindness(partial or complete, severe chest pain, sudden severe headache, vomiting, dizziness, or fainting, weakness in an arm or leg, or trouble speaking, yellowing of the skin and/or white of the eyes indicating possible liver problems.

Other risks of progesterone include: Headache, breast tenderness, bloating or fluid retention, mood swings and depression, irritability and drowsiness.

Call your doctor immediately if you have abnormal vaginal bleeding.

These are not all the side effects with ENDOMETRIN. Ask your doctor or pharmacist for more information.

Tell your healthcare provider if you have any side effects that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088