Dienogest

COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

• • Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) • The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of >30 kg/m 2 has not been evaluated.

• Natazia is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] • Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] • Have coronary artery disease [see Warnings and Precautions ( 5.1 )] • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )] • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] • Have uncontrolled hypertension [see Warnings and Precautions ( 5.4 )] • Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.6 )] • Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions ( 5.7 )] • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (…contraindicated

• Take one tablet daily by mouth at the same time every day. ( 2.1 ) • Tablets must be taken in the order directed on the blister pack. ( 2.1 ) • Do not skip or delay intake by more than 12 hours. ( 2.1 ) 2.1 How to Take Natazia To achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling. 2.2 How to Start Natazia Instruct the patient to begin taking Natazia on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). See FDA-Approved Patient Labeling . Instruct the patient to use a non-hormonal contraceptive as back-up during the first 9 days. For postpartum women who do not breastfeed or after a second trimester abortion, start Natazia no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Natazia postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Natazia for 9 consecutive days. The possibility of ovulation and conception prior to initiation of medication should also be considered. If the patient is switching from a combination hormonal method such as: • Another pill • Vaginal ring • Patch • Instruct her to take the first dark yellow pill on the first day of her withdrawal bleed.

• Vascular risks : Stop Natazia if a thrombotic event occurs. Stop Natazia at least 4 weeks before and through 2 weeks after major surgery. Start Natazia no earlier than 4 weeks after delivery, in women who are not breastfeeding. ( 5.1 ) • Liver disease : Discontinue Natazia if jaundice occurs. ( 5.3 ) • High blood pressure : Do not prescribe Natazia for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.4 ) • Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Natazia. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.6 ) • Headache : Evaluate significant change in headaches and discontinue Natazia if indicated. ( 5.7 ) • Uterine bleeding : Evaluate irregular bleeding or amenorrhea. ( 5.8 ) • CYP3A4 induction : Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose Natazia as their oral contraceptive due to the possibility of decreased contraceptive efficacy. ( 5.13 , 7.1 ) 5.1 Thromboembolic Disorders and Other Vascular Problems Stop Natazia if an arterial or venous thrombotic event (VTE) occurs. The use of COCs increases the risk of venous thromboembolism. However, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Vascular events [see Warnings and Precautions ( 5.1 )] • Liver disease [see Warnings and Precautions ( 5.3 )] Adverse reactions commonly reported by COC users are: • Irregular uterine bleeding • Nausea • Breast tenderness • Headache The most common adverse reactions (≥ 2%) in clinical trials for Natazia are headache (including migraines) 13%, breast pain 7%, menstrual disorders 7%, nausea/vomiting 6%, acne 4%, mood changes (3%) and increased weight 3%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Contraception and Heavy Menstrual Bleeding Studies A total of 2,131 women, 18 to 54 years of age, who took at least one dose of Natazia were enrolled in four clinical phase 3 trials.

• Lactation: can decrease milk production. ( 8.2 ) • Body Mass Index: The safety and efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. ( 8.8 ) 8.1 Pregnancy Risk Summary There is no reason to use COCs in pregnancy Discontinue Natazia if pregnancy occurs. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs prior to conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. 8.2 Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other forms of contraception until she discontinues breastfeeding. [See also Dosage and Administration ( 2.2 )]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Natazia and any potential adverse effects on the breast-fed child from Natazia or from the underlying maternal condition.

Metabolism

Absorption After oral administration of estradiol valerate, cleavage to 17β-estradiol and valeric acid takes place during absorption by the intestinal mucosa or in the course of the first liver passage. This gives rise to estradiol and its metabolites, estrone and other metabolites.

There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

• May 6, 2010NDANDA022252Bayer Hlthcare

1. 1Metrorrhagia3511%
2. 2Drug Dose Omission3411%
3. 3Headache175.5%
4. 4Vaginal Haemorrhage154.8%
5. 5Menstruation Delayed123.9%
6. 6Off Label Use123.9%
7. 7Pregnancy On Oral Contraceptive123.9%
8. 8Nausea113.5%
9. 9Product Use Issue113.5%
10. 10Amenorrhoea103.2%
11. 11Inappropriate Schedule Of Drug Administration92.9%
12. 12Vomiting92.9%
13. 13Abnormal Withdrawal Bleeding82.6%
14. 14Menorrhagia82.6%
15. 15No Adverse Event82.6%

The 10 most recently updated of 86 ClinicalTrials.gov registrations naming Dienogest as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Postoperative Hormonal Therapy and Recurrence After Surgery for Ovarian Endometrioma
  Completed · Observational · 1,121 enrolled · Guangdong Women and Children Hospital
  NCT07519213updated 2026-06-01
• MRI-Based Prediction of Dienogest Response in Endometriosis
  Recruiting · Observational · 48 enrolled · Chungnam National University Sejong Hospital
  NCT07446608updated 2026-03-03
• Ovarian Blockade During Fertility Preservation in Patients With Endometriosis
  Completed · Observational · 130 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT06106919updated 2025-12-10
• Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
  Recruiting · Interventional · 90 enrolled · Centre Hospitalier Universitaire de Nice
  NCT06504953updated 2025-10-02
• Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis
  Active not recruiting · Observational · 138 enrolled · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  NCT07204093updated 2025-10-02
• Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
  Recruiting · Phase 3 · Interventional · 290 enrolled · Alcea
  NCT07164183updated 2025-09-18
• "Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition
  Completed · Interventional · 40 enrolled · Chulalongkorn University
  NCT06396208updated 2025-05-14
• The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
  Completed · Interventional · 10 enrolled · Indonesia University
  NCT06438744updated 2025-05-06
• Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy
  Recruiting · Observational · 90 enrolled · University of Udine
  NCT06414720updated 2025-04-02
• The Progression From Dysmenorrhoea to Chronic Pelvic Pain
  Completed · Observational · 56 enrolled · University of Adelaide
  NCT02636972updated 2025-03-28

Frequently asked questions

How does Dienogest work?

COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

What is Dienogest used for?

According to FDA labeling, Dienogest carries indications including: • Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) • The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of >30 kg/m 2 has not been evaluated.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dienogest?

Dienogest is classified as Pregnadien derivatives, Progestin, Androgen Receptor Antagonists, Progestational Hormone Receptor Agonists, Decreased Embryonic Implantation, Increased Coagulation Activity, Inhibit Ovulation.

What are the contraindications for Dienogest?

Dienogest labeling lists contraindications including: Natazia is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] • Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] • Have coronary artery disease [see Warnings and Precautions ( 5.1 )] • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )] • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] • Have uncontrolled hypertension [see Warnings and Precautions ( 5.4 )] • Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.6 )] • Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions ( 5.7 )] • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (…. Always consult the full prescribing information and a clinician.