Segesterone

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

• ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. ANNOVERA is a progestin/estrogen CHC indicated for use by females of reproductive potential to prevent pregnancy.

• ANNOVERA 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 females who are known to: - Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ].contraindicated

One ANNOVERA is inserted in the vagina. The vaginal system must remain in place continuously for 3 weeks (21 days) followed by a 1-week (7-day) vaginal system-free interval. One vaginal system provides contraception for thirteen 28-day cycles (1 year). ( 2 ) 2.1 How to Use ANNOVERA Instruct patients that ANNOVERA should be used as directed [see How to Start ANNOVERA (2.2) ] . One ANNOVERA should be placed in the vagina. For maximum contraceptive effectiveness, ANNOVERA is to remain in the vagina continuously for 21 days (3 complete weeks). It is removed for a 1-week dose-free interval, and during this time a withdrawal bleed usually occurs. The removed vaginal system should be cleaned with mild soap and warm water, patted dry with a clean cloth towel or paper towel, and placed in its case during the 1-week dose- free interval. At the end of the dose-free interval, the vaginal system should be cleaned prior to being placed back in the vagina for another 21 continuous days (3 complete weeks). This pattern of ANNOVERA use made up of 3-weeks in and 1-week out is a cycle of use; one ANNOVERA vaginal system will provide contraception for 13 cycles. With clean hands, the user can choose an insertion position that is comfortable, such as lying down, squatting, or standing. The sides of the vaginal system are pressed together for insertion into the vagina. When properly inserted, the vaginal system should be entirely in the vagina and behind the pelvic bone.

Thrombotic Disorders and Other Vascular Problems: Stop ANNOVERA if a thrombotic or thromboembolic event occurs. Stop ANNOVERA at least 4 weeks before and through 2 weeks after major surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in females who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. ( 5.1 , 5.5 ) Liver Disease: Discontinue if jaundice occurs. ( 5.2 ) Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment: Stop ANNOVERA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be restarted 2 weeks following completion of this regimen. ( 5.3 ) Hypertension: Do not prescribe ANNOVERA for females with uncontrolled hypertension or hypertension with vascular disease. If used in females with well-controlled hypertension, monitor blood pressure and stop use if blood pressure rises significantly. ( 5.4 ) Carbohydrate and lipid metabolic effects: Monitor glucose in pre-diabetic and diabetic females taking ANNOVERA. Consider an alternate contraceptive method for females with uncontrolled dyslipidemias. ( 5.7 ) Headache: Evaluate significant change in headaches and discontinue ANNOVERA if indicated. ( 5.8 ) Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes if irregular bleeding or amenorrhea persists. ( 5.9 ) 5.1 Thromboembolic Disorders and Other Vascular Conditions Females are at increased risk for a venous thrombotic event (VTE) when using ANNOVERA.

The following adverse reactions are described elsewhere in other sections of 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 (5.2) ] The most common adverse reactions (>5%) are headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, abdominal pain lower/upper, dysmenorrhea, vaginal discharge, urinary tract infection, breast tenderness/pain/discomfort, bleeding irregularities including metrorrhagia, diarrhea, genital pruritus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical trials that evaluated the safety of ANNOVERA were obtained from three 13- cycle trials. One trial was conducted entirely in the U.S. (15 sites), and the other two were global studies that included 5 U.S. sites and 7 international sites (Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, Sweden). All three trials were open label and enrolled healthy females, desiring contraception, 18 to 40 years of age. At about 50% enrollment, females with BMI >29 kg/m 2 were excluded due to the occurrence of two VTEs in this subgroup.

Pregnancy: Discontinue if pregnancy occurs. ( 8.1 ) Lactation: Not recommended for nursing mothers; can decrease milk production. ( 8.2 ) 8.1 Pregnancy Risk Summary Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before 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 2–4% and 15–20%, respectively. Discontinue ANNOVERA if pregnancy occurs, because there is no reason to use CHCs during pregnancy. Data Human Data No studies have been conducted of the use of ANNOVERA in pregnant females. 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. Advise the nursing female to use another method of contraception until she discontinues breastfeeding [see Dosage and Administration (2.2) ] . Data Human Data No studies have been conducted of the use of ANNOVERA in breastfeeding females.

Metabolism

Absorption The pharmacokinetics (PK) of ANNOVERA were determined in 39 women who used ANNOVERA for up to 13 cycles. Following vaginal administration, SA and EE were absorbed into systemic circulation with median t max of about 2 hours in Cycle 1, Cycle 3, and Cycle 13.

There have been no reports of serious ill effects from overdose of CHCs. Overdosage may cause withdrawal bleeding in females and nausea. In case of suspected overdose, all ANNOVERA vaginal systems should be removed and symptomatic treatment given.

• Aug 10, 2018NDANDA209627Mayne Pharma

1. 1Intermenstrual Bleeding4011%
2. 2Nausea349.7%
3. 3Off Label Use349.7%
4. 4Vaginal Haemorrhage339.4%
5. 5Drug Ineffective257.1%
6. 6Headache216.0%
7. 7Vaginal Discharge174.8%
8. 8Vomiting174.8%
9. 9Device Expulsion144.0%
10. 10Pulmonary Embolism133.7%
11. 11Depression123.4%
12. 12Metrorrhagia123.4%
13. 13Migraine123.4%
14. 14Abdominal Pain113.1%
15. 15Menstrual Disorder113.1%

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Segesterone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Vaginal Estradiol and Oral Guaifenesin in Clomiphene Ovulation Induction
  Completed · Interventional · 90 enrolled · Yuzuncu Yil University
  NCT07398924updated 2026-02-10
• Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males
  Completed · Phase 1 · Interventional · 26 enrolled · Kimberly Myer
  NCT02994602updated 2026-02-09
• Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring
  Completed · Phase 3 · Interventional · 1,200 enrolled · Premier Research
  NCT00455156updated 2026-01-23
• A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women
  Completed · Phase 2 · Interventional · 197 enrolled · Kimberly Myer
  NCT01586000updated 2025-12-08
• Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring
  Completed · Phase 2 · Interventional · 385 enrolled · Premier Research
  NCT03432416updated 2025-10-31
• Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception
  Completed · Phase 2 · Interventional · 420 enrolled · Premier Research
  NCT03452111updated 2025-02-18
• Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
  Completed · Phase 1 · Interventional · 44 enrolled · Kimberly Myer
  NCT02432261updated 2025-02-13
• The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
  Completed · Phase 1 · Interventional · 21 enrolled · TherapeuticsMD
  NCT04272008updated 2021-10-29
• Annovera™ Drug-Drug Interaction Study
  Completed · Phase 1 · Interventional · 67 enrolled · TherapeuticsMD
  NCT04290390updated 2021-01-29
• The Vaginal Health Trial
  Completed · Phase 3 · Interventional · 302 enrolled · Fred Hutchinson Cancer Center
  NCT02516202updated 2018-07-12

Frequently asked questions

How does Segesterone work?

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

What is Segesterone used for?

According to FDA labeling, Segesterone carries indications including: ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. ANNOVERA is a progestin/estrogen CHC indicated for use by females of reproductive potential to prevent pregnancy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Segesterone?

Segesterone is classified as Progestin, Inhibit Ovulation.

What are the brand names for Segesterone?

Segesterone is marketed under brand names including Annovera.

What are the contraindications for Segesterone?

Segesterone labeling lists contraindications including: ANNOVERA 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 females who are known to: - Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ].. Always consult the full prescribing information and a clinician.