In short
Dienogest is a progestin, a synthetic form of the female hormone progesterone, used in the management of endometriosis and as a component of combined hormonal contraceptives. It is an authorised medicine in several EU countries, including Spain, where it is available as a film-coated tablet in combination with ethinylestradiol.
Key points
- Dienogest is an authorised progestin medicine used for endometriosis and in combined hormonal contraceptives.
- One CTIS trial investigates dienogest with drospirenone for ovulation inhibition in a Phase 2 study with 180 healthy premenopausal women.
- A second CTIS trial uses a dienogest/ethinylestradiol combination as the standard treatment comparator in a 120-participant endometriosis study of cabergoline.
- The Phase 2 contraception trial measures ovulation incidence using the Hoogland-Skouby score over treatment cycles 1 to 3.
- The endometriosis trial is currently authorised, and so is the contraception trial.
- Dienogest is given orally as a film-coated tablet, typically at a strength of 2 mg.
What is dienogest?
Dienogest is a progestin, a synthetic form of progesterone, and belongs to the therapeutic area of female urogenital diseases and pregnancy complications. It is available in a fixed combination with ethinylestradiol as a film-coated tablet for oral use, authorised in Spain under the product name Sibilla diario 2 mg / 0.03 mg. In the United Kingdom, dienogest 2 mg tablets are listed in the NHS dm+d browser as a standalone product. In the CTIS records, dienogest is listed as a comparator in one trial, meaning it is already used as a reference treatment in endometriosis research.
How does dienogest work?
Dienogest acts on progesterone receptors in the body, producing effects similar to the natural hormone progesterone. In the endometriosis trial, a dienogest-containing product is used as the standard treatment against which cabergoline is compared, indicating that dienogest is an established option for reducing endometriosis symptoms. In the contraception trial, dienogest is combined with drospirenone to investigate ovulation inhibition, meaning the combination is intended to stop the release of an egg from the ovary.
Which conditions is dienogest used or studied for?
- Endometriosis — a condition where tissue similar to the lining of the womb grows outside it, causing pelvic pain. Dienogest is an approved third-line treatment option for endometriosis in the East and North Hertfordshire NHS Trust formulary, for patients when combined hormonal therapy and other progestogen-only therapies have not been tolerated or have been ineffective.
- Contraception — prevention of pregnancy in healthy premenopausal women. A Phase 2 trial is investigating different dose combinations of dienogest and drospirenone for ovulation inhibition, including after intentional 24-hour intake errors.
How is dienogest given?
Dienogest is given orally as a film-coated tablet. The authorised product in Spain combines 2 mg dienogest with 0.03 mg ethinylestradiol per tablet. In the NHS dm+d browser, a standalone dienogest 2 mg tablet pack of 28 tablets is listed. In the endometriosis trial, the dienogest-containing product is taken as one tablet daily by mouth, and in the contraception trial dienogest is given orally in two different strengths.
What do the clinical trials show?
Two CTIS trials involve dienogest, both currently authorised. In the endometriosis study, dienogest is part of the standard treatment control group, not the investigational drug; the trial evaluates whether cabergoline can reduce endometriotic lesion size and pelvic pain compared with standard treatment such as dienogest or combined contraceptives. In the contraception study, dienogest is the investigational substance, tested in combination with drospirenone in a Phase 2 trial with 180 healthy premenopausal women.
What is being measured in these trials?
The endometriosis trial measures reduction in the size of endometriotic lesions by transvaginal ultrasound, MRI or laparoscopy, and relief of pelvic pain on a visual analogue scale before and after treatment. The contraception trial measures ovulation incidence in treatment cycles 1 to 3, defined as a Hoogland-Skouby score of 5 or 6, which indicates that ovulation has occurred.
Who can take part in these trials?
The endometriosis trial enrols 120 women with confirmed endometriosis. The contraception trial enrols 180 healthy premenopausal female participants.
What side effects are known?
The provided supplementary sources do not report specific side effects for dienogest, so no side-effect information is included on this page.