Visanne (dienogest), marketed by Bayer, is a hormonal contraceptive that is used either alone or in combination with estradiol.
In endometriosis, the medication is used to reduce pain and the size of endometrial lesions.
While Visanne is approved for the treatment of endometriosis in Europe and several countries in Latin America and Asia-Pacific, it has not been approved by the U.S. Food and Drug Administration (FDA).
How Visanne works
Visanne is a synthetic progesterone-like hormone (progestin). Progesterone plays a crucial role in the menstrual cycle, as it prepares the uterus for the potential implantation of a fertilized egg. It also opposes the action of estrogen; estrogen stimulates the growth of endometrial lesions while progestins such as Visanne can inhibit the growth of those lesions.
Visanne in clinical trials
A randomized placebo-controlled Phase 3 clinical trial (NCT01822080) assessed the safety and effectiveness of Visanne for treating endometriosis. A total of 255 women with endometriosis were randomized to receive either 2 mg of oral Visanne per day, or a placebo.
After 24 weeks of treatment, the pelvic pain score of the women taking Visanne was reduced by 67%, and by 26% in those taking placebo compared to the start of the trial. The treatment also resulted in an overall improvement in women’s quality of life. Visanne was well-tolerated and did not decrease bone marrow density, a common side effect of hormonal contraceptives.
Another randomized Phase 3 clinical trial (NCT00225199) assessed the effectiveness and safety of Visanne compared to placebo. A total of 198 women with endometriosis-associated pelvic pain received either 2 mg of oral Visanne per day or a placebo for 12 weeks.
The primary outcome was a reduction in pelvic pain, which was measured on a visual analog scale (VAS) where 0 mm represents the absence of pain, and 100 mm represents unbearable pain.
After 12 weeks of treatment, the VAS score was reduced by 27.4 mm in the Visanne group and by 15.1 mm in the placebo group, compared to the start of the trial. The difference was statistically significant. Visanne was well-tolerated with few adverse side effects.
The study also assessed whether the use of pain relief medication changed during the intervention. The use of supportive pain relief medication was decreased in both groups, but there was no significant difference between the groups.
An ongoing randomized clinical trial (NCT03142035) at Lebanon’s American University of Beirut Medical Center seeks to compare the effect of Visanne with that of a GnRH receptor agonist on the fertility of women with endometriosis undergoing in-vitro fertilization (IVF). The trial is currently recruiting patients.
A Phase 4 clinical trial (NCT02575248) in Abbasia, Egypt, sought to assess whether Visanne can improve the fertility outcome in women with stage 1 or 2 endometriosis. Participants were randomized to receive either 2 mg of oral Visanne per day, or no treatment for three months. Both groups then received 5 mg of clomiphene citrate for three months to induce ovulation. The trial was supposed to be completed in July 2017 but its current status is unknown.
Another Phase 4 clinical trial (NCT03789123) at the Bagcilar Research and Training Hospital in Istanbul, Turkey, is assessing the effect of Visanne treatment on endometriomas (ovarian cysts). Participants will receive either Visanne alone, Visanne in combination with estradiol, or no therapy for up to 24 months. Outcome measures are ovarian reserve (number of remaining eggs in the ovaries), endometrioma size, and pain score. The trial is still recruiting patients.
A more recent study in Italy investigated the effect of Visanne over 24 months on the quality of life and sexual function of women with endometriosis pain. A total of 54 women were given Visanne and a control group of 38 women were given non-steroidal anti-inflammatory drugs (NSAIDs) for 24 months. The study found significant improvements in chronic pelvic pain, dyspareunia, and dysmenorrhea, as well as all quality of life measurements for the Visanne group; no change was observed for the NSAIDs (control) group.
Last updated: Aug. 5, 2019
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