Dydrogesterone

Dydrogesterone (INN, USAN, BAN), also known as 9β,10α-pregna-4,6-diene-3,20-dione, is a steroidal progestin. It is sold under the brand name Duphaston, which is manufactured by Abbott (formerly Solvay Pharmaceuticals).

Dydrogesterone was first introduced to the market in 1961, and is currently approved in over 100 countries worldwide. It has an estimated cumulative exposure of more than 28 million patients.

Dydrogesterone is a potent, orally active progestogen indicated in a wide variety of gynaecological conditions. Although similar in molecular structure and pharmacological effects to endogenous progesterone. It is orally active at far lower doses. Its freedom from estrogenic, androgenic, anabolic, corticoid and other undesirable hormonal effects gives it additional benefits over most other synthetic progestogens.

The therapeutic use of dydrogesterone is closely related to its physiological action on the neuro-endocrine control of ovarian function, as well as on the endometrium. As such, it is indicated in all cases of relative or absolute endogeneous progesterone deficiency.

Dydrogesterone is to be withdrawn from the UK market from March 2008 for commercial reasons. Dydrogesterone was licensed for use in several indications,including threatened or recurrent miscarriage, dysfunctional uterine bleeding, and hormone replacement therapy.

Dydrogesterone has proven effective in the following conditions:

• menstrual disorders
• infertility
• threatened and habitual abortion. Dydrogesterone is not approved for this indication by any regulatory body in US, Canada, EU or Australia.
• endometriosis
• premenstrual syndrome

Dydrogesterone has also been registered as hormone replacement therapy (HRT) to counteract the negative effects of unopposed estrogen on the endometrium. Dydrogesterone is relatively safe and well tolerated, and does not exhibit the androgenic side effects that are common with some other progestins, like medroxyprogesterone.