Visanne (Dienogest 2 mg) for Endometriosis: Trial Results, Side Effects and Where It Is Available

Visanne is Bayer's brand of dienogest 2 mg, a progestin tablet taken every day without a break to treat pain from endometriosis. It is sold in Canada, Australia, much of Europe and India. It is not sold in the US, and no dienogest-only tablet has FDA approval, which is why many American women search for Visanne from Canada or overseas.

This guide sets out what the trials behind Visanne measured, how it compares with placebo and with monthly GnRH agonist injections, what happens to bleeding and bone density, who must not take it, and what women in the US, UK, Canada and Australia can actually get. We sell Visanne 2 mg, so we have a commercial interest in it; the evidence below is reported as the sources give it, including the parts that are less flattering. Every number comes from the Canadian product monograph, the EU product information or a published trial, listed at the end.

The short answer

In a 12-week double-blind trial of 198 women with surgically confirmed endometriosis, pelvic pain fell by 27.4 mm on a 100 mm scale with dienogest 2 mg, against 15.1 mm on placebo, a difference of 12.3 mm. About 1 in 3 women on dienogest halved their pain, compared with about 1 in 7 on placebo. In a 24-week trial against leuprorelin (leuprolide) injections, pain relief was similar, and bone density held steady on dienogest while it fell about 4% on leuprorelin. The trade-off is bleeding: most women have irregular or prolonged spotting at first, which settles for many by the end of the first year. Headache and breast discomfort were the most common side effects. Visanne is not a contraceptive, and it should not be combined with hormonal birth control.

What Visanne is

Item	Detail
Active ingredient	Dienogest 2 mg, a progestin
Brand owner	Bayer
Licensed use (Canada)	Management of pelvic pain associated with endometriosis
Licensed use (Australia)	Treatment of endometriosis
Dose	One tablet every day without a break, at about the same time
Half-life	About 9 to 10 hours
Status	Prescription only in Canada and Australia; no FDA approval in the US

Dienogest is also one of the two hormones in Natazia, a combined birth control pill sold in the US with estradiol valerate. That is a different product with a different purpose. It is not a substitute for Visanne, and the Visanne monograph says hormonal contraceptives should not be used together with it.

How dienogest treats endometriosis

Endometriosis is tissue similar to the lining of the womb growing outside the womb. It is driven by oestrogen, which is why hormone treatments that lower oestrogen's effect are used for the pain.

The Canadian monograph explains that dienogest reduces the body's own production of estradiol and, taken continuously, creates a high-progestin, moderately low-oestrogen environment. That makes endometriosis tissue less active. In a study of 20 healthy women, 2 mg a day stopped ovulation after one month. Oestrogen is only moderately lowered. GnRH agonists such as leuprorelin suppress it more strongly, and in the trial below they caused more low-oestrogen effects such as hot flushes, and a fall in bone density.

Pain relief against placebo

The placebo-controlled trial (Study 307041, published by Strowitzki and colleagues in 2010) ran for 12 weeks at 33 centres in Germany, Italy and Ukraine. Women were 18 to 45, had endometriosis confirmed at surgery and a pelvic pain score of at least 30 mm on a 0 to 100 mm visual analogue scale. Both groups could take ibuprofen.

Pelvic pain score (mm, mean)	Placebo (n=96)	Visanne 2 mg (n=102)
Start	57.0	56.8
Week 4	50.8	41.2
Week 8	44.2	30.6
Week 12	39.4	27.6
Change to week 12	-15.1	-27.4

The difference of 12.3 mm (95% CI 6.4 to 18.1) was statistically significant. Ibuprofen use fell in both groups and did not differ between them, so the pain improvement was not explained by extra painkillers. The gap opened by week 4, was largest at week 8 and held to week 12.

How many women got a large benefit

Averages hide the spread. The monograph also reports how many women had a large fall in pain without a relevant increase in painkillers.

Fall in pelvic pain at 12 weeks	Placebo	Visanne 2 mg
50% or more	13.5%	32.4%
75% or more	5.2%	18.6%

Put plainly, about two in three women on Visanne had not halved their pain after three months. Some of them may improve further with longer use (see below), but it is not a guaranteed fix. The EU product information quotes higher responder figures for the same trial (37.3% vs 19.8% for a 50% reduction), apparently from a different analysis. We use the Canadian monograph figures throughout so the numbers come from one analysis.

What happens with longer use

An open-label extension (Study 307059) gave dienogest for another 52 weeks to 168 women from the placebo trial. Pain kept falling. In women who had dienogest from the start, the mean score went from 56.4 mm to 9.7 mm; the mean change reported over 64 weeks was -44.2 mm. For women who switched from placebo it was -41.9 mm. The monograph notes that efficacy has not been tested beyond 15 months.

Pelvic pain score (mm, mean)	Dienogest from start (n=87)	Placebo, then dienogest (n=81)
Start of first trial	56.4	57.5
Week 12 (end of first trial)	27.9	40.7
Week 28 of extension	16.1	19.5
Week 52 of extension	9.7	13.5

Open-label extensions have no comparison group and lose women who stopped, so they tend to look better than a controlled trial would. They show that pain relief was kept up in women who stayed on treatment, not how much of the fall was the drug.

Visanne versus leuprorelin injections

GnRH agonists such as leuprorelin (sold as Lupron Depot in the US) are an established endometriosis treatment. Study 97085 randomised 252 women to dienogest 2 mg daily or leuprorelin 3.75 mg injected every 4 weeks for 24 weeks. It was open-label and designed to show that dienogest was not worse.

Measure at 24 weeks	Visanne 2 mg	Leuprorelin 3.75 mg
Fall in pelvic pain (mm, per-protocol)	47.5	46.0
Pain down 50% or more	82.2%	85.4%
Pain down 75% or more	74.4%	69.8%
Lumbar spine bone density change	+0.25%	-4.04%
Completed the trial	87.9%	93.8%

Non-inferiority was shown (P<0.0001). The published paper reports that hot flushes and other low-oestrogen effects were less frequent on dienogest, and that bleeding episodes were suppressed less than with leuprorelin. The bone result is the main practical difference. In the monograph's subset, mean bone density did not fall in 21 women after 6 months of dienogest, while it fell 4.04% in 29 women on leuprorelin (difference 4.29%, P=0.0003).

Bleeding changes: the main thing to expect

Visanne changes the bleeding pattern in most women. The monograph pooled bleeding diaries from the main trials.

Bleeding pattern	Days 1 to 90 (n=290)	Days 271 to 360 (n=149)
Prolonged bleeding	38.3%	4.0%
Irregular bleeding	35.2%	21.5%
Infrequent bleeding	27.2%	24.2%
Normal bleeding	19.7%	22.8%
Frequent bleeding	13.4%	2.7%
No bleeding (amenorrhoea)	1.7%	28.2%

Mean days of bleeding or spotting fell from 25.1 in the first 90 days to 10.2 in the fourth 90-day period. Fewer than 1% of women stopped because of bleeding changes. Keep taking the tablets through spotting: the monograph says they must be taken continuously regardless of vaginal bleeding.

Heavy bleeding is a different matter. The monograph warns that bleeding may get worse in women with adenomyosis or fibroids, and that heavy, persistent bleeding can lead to anaemia. Report heavy or prolonged bleeding to your doctor; stopping Visanne may need to be considered.

Side effects

The monograph lists side effects with a possible or probable link to Visanne at 1% or more, pooled from three main trials with 303 women. The most frequent were headache (6.6%) and breast discomfort (5.3%).

Side effect	Women (n=303)
Headache	6.6%
Breast discomfort (engorgement or pain)	5.3%
Weight gain	3.6%
Nausea	3.6%
Depressed mood	3.0%
Ovarian cyst	2.6%
Sleep disorder	2.3%
Tiredness or weakness	2.3%
Acne	2.0%
Loss of libido	1.7%
Abdominal pain	1.7%
Hair loss	1.3%
Nervousness, irritability, migraine, bleeding or spotting	1.3% each

This table has no placebo column, so it shows how often each effect was reported and judged possibly related, not how much more often than on placebo. The EU product information gives higher figures: headache 9.0%, breast discomfort 5.4%, depressed mood 5.1% and acne 5.1%.

Mood and depression

Low mood is the side effect to watch most closely. The monograph says women with a history of depression should be carefully observed, and Visanne should be stopped if clinically relevant depression occurs or existing depression gets worse. Anxiety, mood swings and altered mood are listed among less common reactions. If your mood drops after starting, tell your doctor rather than waiting for the next review.

Bone density, especially in teenagers

In adults, the bone data are reassuring but short. Mean bone density did not fall over 6 months in the leuprorelin trial subset, and the monograph notes that long-term data on bone density and fracture risk are not available.

Teenagers are different. In a 12-month study of 111 girls aged 12 to under 18, Visanne eased pain, but lumbar spine bone density fell by a mean of 1.2%. It increased towards pre-treatment levels over the 6 months after stopping. The monograph's boxed warning says this loss may not be completely reversible, may be greater with longer use, and that it is unknown whether it reduces peak bone mass and raises the risk of osteoporosis. It asks doctors to re-evaluate risks and benefits in teenagers regularly, to consider bone density monitoring, and to make sure intake of calcium and vitamin D is adequate. Visanne is not intended before the first period.

Ovarian cysts

Persistent ovarian follicles, often called functional ovarian cysts, can develop on Visanne. The monograph says most cause no symptoms, though some come with pelvic pain. Ovarian cyst was reported in 2.6% of women in the main trials. Persistent new pelvic pain on treatment should be checked, not assumed to be endometriosis.

Who must not take Visanne

The Canadian monograph lists these contraindications, partly taken from other progestin-only products. If any appears during treatment, Visanne must be stopped straight away.

• Known or suspected pregnancy, or breastfeeding
• An active blood clot in a vein (venous thromboembolism)
• Arterial or heart disease, past or present, such as heart attack, stroke or ischaemic heart disease
• Diabetes with blood vessel involvement
• Severe liver disease, now or in the past, until liver tests are back to normal; liver tumours, benign or malignant
• Known or suspected sex hormone-dependent cancers
• Undiagnosed abnormal vaginal bleeding
• Eye disease caused by blood vessel problems, such as loss of vision or visual field defects
• Migraine with focal aura, now or in the past
• Allergy to dienogest or any ingredient (the tablets contain lactose)

Pregnancy must be excluded before starting. The monograph also advises stopping Visanne at least 4 weeks before planned surgery or long immobilisation, and not restarting until 2 weeks after full mobility, because some studies suggest a small, not statistically significant, increase in clot risk with progestin-only products.

Other warnings in the monograph

• Visanne should be stopped straight away if a blood clot in a vein or artery is suspected or causes symptoms. Get urgent medical help for symptoms of a clot.
• If sustained, clinically significant high blood pressure develops, stopping Visanne and treating the blood pressure is advised.
• Dienogest may slightly reduce insulin sensitivity. Women with diabetes, especially those who had diabetes in pregnancy, should be carefully observed.
• If jaundice or itching that first appeared in pregnancy or with earlier sex hormone use comes back, Visanne must be stopped.
• Smoking increases the risk of serious heart and blood vessel effects and may add to bone density loss. The monograph advises not smoking.

Contraception while taking Visanne

Visanne stops ovulation in most women but has not been tested as a contraceptive and is not meant to be used as one. The monograph advises a non-hormonal method, such as condoms or a diaphragm, if you need contraception, and says hormonal contraceptives should not be used with it. Pregnancies on progestin-only products are more likely to be ectopic than on combined pills, so if you become pregnant, the monograph says Visanne must be stopped; see your doctor promptly. For women with a past ectopic pregnancy or fallopian tube problems, the monograph says Visanne should be considered only after carefully weighing benefits against risks. After stopping, the cycle returns to its pre-treatment pattern within about 2 months.

Medicines that interact

Medicine	Effect on dienogest
Enzyme inducers: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, St John's wort; possibly oxcarbazepine, topiramate, felbamate, griseofulvin	Lower levels, so Visanne may work less well. In a study with estradiol valerate and dienogest, rifampicin cut dienogest exposure by 83%. The effect can last about 4 weeks after the inducer is stopped.
Strong and moderate CYP3A4 inhibitors: ketoconazole, itraconazole, voriconazole, fluconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice	Higher levels. Ketoconazole raised exposure 2.9-fold and erythromycin 1.6-fold.
Many HIV and hepatitis C protease inhibitors and NNRTIs	Levels may go up or down
Other steroids, including danazol	The monograph says Visanne should not be prescribed at the same time

Visanne is not expected to change the levels of other medicines, based on laboratory studies. Vomiting or diarrhoea within 3 to 4 hours of a tablet can reduce absorption; the monograph says to take a replacement tablet.

Missed tablets

If you miss a tablet, take one tablet only as soon as you remember, then take the next at the usual time the next day. Do not double up. The monograph warns that missed tablets, vomiting or diarrhoea can make Visanne less effective. Start the next pack the day after the last one, with no break between packs.

Can you get Visanne in the US, UK, Canada and Australia?

Country	Status of dienogest 2 mg
United States	No FDA application for dienogest alone or for Visanne. Dienogest is only available in Natazia (estradiol valerate with dienogest) and its generic, both combined birth control pills.
Canada	Visanne (Bayer Inc.) marketed since October 2011, prescription only. Several generic dienogest 2 mg products are also listed by Health Canada.
United Kingdom	No Visanne licence; generic dienogest 2 mg (including Dimetrum, Sawis and Endovelle) is licensed. NHS Drug Tariff price £20.50 for 28 tablets.
Australia	Visanne on the ARTG, Schedule 4 prescription medicine. PBS listed (Authority Required, streamlined) with Dinasane; general patient charge AU$25.00 per 28-tablet pack.
India	Visanne 2 mg sold by Bayer, prescription required.

For US readers, the FDA's personal importation page says that in most circumstances it is illegal for individuals to import unapproved drugs for personal use. The FDA describes limited situations where it may use enforcement discretion for a serious condition, including that effective treatment may not be available in the US and that the product is not commercialized or promoted to US residents. Several FDA-approved endometriosis treatments exist (below), so the first condition is unlikely to be met, and a shipment can be detained. Visanne bought from Canada or India is not an FDA-approved product either way.

FDA-approved alternatives in the US

• Norethindrone acetate 5 mg (generic of Aygestin, a brand now discontinued). A progestin tablet labelled for endometriosis. NADAC lists norethindrone 5 mg tablets at $0.28984 each for the week of 14 October 2026, about $8.70 for 30 tablets at pharmacy cost.
• Orilissa (elagolix), AbbVie. A GnRH receptor antagonist tablet for moderate to severe endometriosis pain; the label limits duration by dose.
• Myfembree (relugolix, estradiol and norethindrone acetate). Labelled for moderate to severe endometriosis pain, use limited to 24 months, with a boxed warning on blood clots and vascular events.
• GnRH agonist injections such as leuprorelin, combined hormonal pills and surgery, depending on the case.

The only randomised trial we found comparing norethindrone acetate 5 mg with dienogest 2 mg (Gurbuz 2025, 70 women, one centre in Turkey) found similar pain relief at 6 and 12 months. More women stopped dienogest by 6 months (47.5% vs 23.3%), and norethindrone acetate shrank endometriomas more. It was small and is one study, but it is the closest head-to-head evidence for the main US option.

Visanne from SafeRxPills

Our Visanne 2 mg is the Bayer brand for the Indian market. Before you consider it:

• It is not an FDA-approved product, and the FDA import rules above apply to it.
• Endometriosis should be diagnosed by a doctor. The trials enrolled women with endometriosis confirmed at surgery; pelvic pain has other causes that need different treatment.
• Check the contraindications above, rule out pregnancy and plan non-hormonal contraception.
• Teenagers should only use it with a specialist weighing the bone density effect.

For related reading, see our guides to progestins and withdrawal bleeding, birth control pills and blood clot risk and progesterone for luteal phase support. Browse other women's health medicines.

Questions to ask your doctor

• Has my endometriosis been confirmed, or should other causes of my pain be ruled out first?
• Is a progestin like dienogest or norethindrone acetate the right first step for me, or would a combined pill, a GnRH medicine or surgery suit me better?
• How should I handle the irregular bleeding in the first months, and what amount of bleeding should make me call you?
• I have a history of depression or migraine. Is Visanne safe for me?
• Which contraception should I use while taking it?
• Do any of my medicines, such as epilepsy drugs, antifungals or HIV medicines, interact with it?
• When should we review whether it is working, and for how long should I take it?

Sources

1. VISANNE (dienogest tablets 2 mg) Product Monograph. Bayer Inc., Canada. Date of revision 16 February 2016. Health Canada Drug Product Database, drug code 86025 (DIN 02374900), status Marketed, original market date 25 October 2011.
2. Visanne 2 mg tablets, Summary of Product Characteristics. Bayer AG. Date of revision April 2020. Sections 4.2 to 4.8, 5.1 and 5.2.
3. Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. European Journal of Obstetrics, Gynecology and Reproductive Biology. 2010. PMID 20444534.
4. Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Human Reproduction. 2010. PMID 20089522.
5. Gurbuz T, et al. Norethindrone acetate versus dienogest for pain relief in endometriosis related pain: a randomized controlled trial. European Journal of Obstetrics, Gynecology and Reproductive Biology. 2025. PMID 40233572.
6. US Food and Drug Administration. Drugs@FDA (openFDA), searched for dienogest, Aygestin and Orilissa, October 2026. Orilissa (AbbVie, label December 2025) and Myfembree (Sumitomo Pharma America, label September 2025) indications; Gallifrey norethindrone acetate 5 mg label (Xiromed).
7. US Food and Drug Administration. Personal Importation (page last updated 18 August 2025).
8. Therapeutic Goods Administration, ARTG 160465 (Visanne); healthdirect Australia; Pharmaceutical Benefits Scheme item 14667Y.
9. MHRA Products database (dienogest 2 mg licences) and NHS dm+d / Drug Tariff, dienogest 2 mg tablets 28 (price from 1 March 2023).
10. Centers for Medicare and Medicaid Services. NADAC, week of 14 October 2026: norethindrone 5 mg tablet.

This guide is for information and does not replace advice from a doctor who knows your medical history. Do not start or stop hormonal treatment for endometriosis without medical advice.