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Dienogest is a synthetic progestin, a substance that acts like the natural female hormone progesterone. It is already authorised as a medicine in Spain, where the product Sibilla diario 2 mg / 0.03 mg film-coated tablets combines dienogest with ethinylestradiol and is marketed by Gedeon Richter Plc.[1] The same fixed-dose combination is authorised in several other EU countries under names such as Dienovel, Jeanine and Motion.[4] In the two CTIS trials listed here, dienogest appears once as a comparator and once as an investigational substance.[1][2]
Dienogest is a progestin, a synthetic form of progesterone, and belongs to the therapeutic area of female urogenital diseases and pregnancy complications.[1] 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.[1] In the United Kingdom, dienogest 2 mg tablets are listed in the NHS dm+d browser as a standalone product.[3] 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.[1]
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.[1] 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.[2]
Dienogest is given orally as a film-coated tablet.[1] The authorised product in Spain combines 2 mg dienogest with 0.03 mg ethinylestradiol per tablet.[1] In the NHS dm+d browser, a standalone dienogest 2 mg tablet pack of 28 tablets is listed.[3] 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.[1][2]
Two CTIS trials involve dienogest, both currently authorised.[1][2] 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.[1] In the contraception study, dienogest is the investigational substance, tested in combination with drospirenone in a Phase 2 trial with 180 healthy premenopausal women.[2]
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.[1] 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.[2]
The endometriosis trial enrols 120 women with confirmed endometriosis.[1] The contraception trial enrols 180 healthy premenopausal female participants.[2]
The provided supplementary sources do not report specific side effects for dienogest, so no side-effect information is included on this page.
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