What is Tibolone?

 



Tibolone is a synthetic steroid hormone that has estrogen, androgen, and progestogen properties. It restores the imbalanced female hormones during menopause and manages night sweats and hot flashes. Also, this is prescribed to women who missed their periods for a year to prevent osteoporosis.

Tibolone is produced by Organon Pharmaceuticals in West Orange, New Jersey. It comes in tablets and has been used in Europe for 2 decades as treatment and prevention of postmenopausal osteoporosis and postmenopausal symptoms. Additionally, it is approved in 90 countries to manage menopause symptoms and in 45 countries to prevent osteoporosis development.

Regulation

The FDA didn’t approve tibolone for use in the United States (Organon Pharmaceuticals received a ‘Not Approvable’ letter from the FDA). The treatment’s increased breast cancer and stroke risks, and its androgenic effects (it can act like male hormones in the body) are the factors contributed to FDAs decision.


Tibolone is approved for use in Australia, Canada, the United Kingdom, various European countries, and several countries in Asia and Latin America.

Ingredients

The tablet contains:
  • Lactose monohydrate
  • Mannitol
  • Potato starch
  • Magnesium stearate
  • Ascorbyl palmitate
It doesn’t contain:
  • Gluten
  • Sucrose
  • Tatrazine
  • Azo dyes

Medication Guidelines

  • Before taking the tablet, read the manufacturer’s printed information inside the pack. It has comprehensive information about the treatment.
  • Take one 2.5 mg tablet at the same time daily. You can take it before or after meals.
  • If you forget to take a dose, you can take it as long as you’re not 12 hours late. Don’t take 2 tablets to make up for the missed dose.
You can’t take Tibolone if you’re:
  • Pregnant or thinking you're pregnant
  • Breastfeeding
  • Breast cancer or has history of it
  • Cancer that's sensitive to estrogen
  • Unexplained vaginal bleeding
  • Untreated endometrial hyperplasia
  • Blood clot in the leg and lungs
  • Blood clotting disorder (protein S, protein C or antithrombin deficiency)
  • Liver disease
  • Disease that's caused by blood clots in the arteries (heart attack, stroke or angina)
  • Inherited blood problem
  • Epilepsy
  • Gallstones
  • Migraine or migraine-like headaches
These are the common side effects that occur in 1% to 10% women using Tibolone:
  • Vaginal bleeding or spotting
  • Abdominal pain
  • Weight gain
  • Breast pain
  • Unnatural hair growth
  • Vaginal discharge, itching, and irritation
  • Rash or itching
  • Visual disturbances
  • Gastro-intestinal upset
  • Fluid retention
  • Joint and muscle pain
  • Liver function changes
Efficacy

Vasomotor symptoms - Randomized trials showed Tibolone 2.5 mg is more effective than placebo in managing hot flashes and night sweats.

Bone health - LIFT’s study (Long-term Intervention on Fractures of Tibolone) with 4538 women respondents (age 60-85 years old) with osteoporosis on minimal trauma vertebral fracture had significant reduction from absolute risk of vertebral and nonvertebral fractures. This fracture risk reduction is seen in women with pre-existing vertebral fracture.

Sexual health - Tibolone’s estrogen and androgen properties improve menopausal women with low libido compared to placebo in clinical trials.

Associated Health Risks

Stroke - Younger women taking Tibolone have the same risk as conventional combined hormone replacement therapy and women over 60 years old will have increased risk of stroke.

Endometrial cancer - One LIFT study revealed that women taking Tibolone were diagnosed with one additional case of endometrial hyperplasia and 4 additional cases of endometrial cancer compared with placebo users after 2.7 years of treatment. Additionally, observational studies showed that risks increased for long term usage.

Breast cancer - The National Institutes of Health study noted Tibolone increases recurring breast cancer rates to women with breast cancer history.

Like any other HRT treatments, Tibolone has advantages and disadvantages depending on the users’ health condition and menopause symptoms. Recent data showed minimal study results but as medical technology progresses, we can expect more data and figures so menopausal women can narrow down their options.






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