NEXTSTELLIS® (DRSP/E4) clinical trial program overview

NEXTSTELLIS is proven through a robust research program in women that included a range of age, BMI, and racial diversity1-5

View the NEXTSTELLIS results delivered against key endpoints in a large, multi-phase clinical trial program1-5

Phase II

4 trials

681 patients

Phase III

2 trials

3,632 patients

NEXTSTELLIS demonstrated efficacy and safety in a robust clinical trial program.
The Phase III patient population included women 16 to 50 years of age and a high-BMI cohort (22% of patients had BMI 30-35 kg/m2).1-3

Contact Medical Affairs

NEXTSTELLIS head-to-head comparison against Yaz® and Nordette®1,2,4,5

In 2 Phase II safety studies, NEXTSTELLIS was studied head-to-head against 2 standard-of-care COCs*:

  • Yaz® (20 mcg EE/3 mg DRSP)
  • Nordette®** (30 mcg EE/150 mcg LNG)

Endpoints included4,5:

  • Hemostasis parameters
  • Endocrine parameters, as well as SHBG
  • Lipid and carbohydrate metabolism parameters
  • Ovulation inhibition

*Both Phase II studies included Yaz® (EE/DRSP) as a comparator; only 1 (C201) included Nordette® (EE/LNG)

**European trade name is Melleva®6

Phase III trial program

Patient demographics reflect a real-world range in age (16-50 years of age), ethnicity, weight, and contraceptive history1-3

NEXTSTELLIS Phase III trial program

The 2 Phase III trials of NEXTSTELLIS studied 3,632 women (ages 16-50 years). The efficacy population in the North American trial was 1,524 (ages 16-35 years), and in the EU/Russian study, it was 1,313 (ages 18-35 years). Women were studied over 12 months for 13 menstrual cycles, totaling 26,455 at-risk cycles.1-3

Patient demographics

CONTRACEPTIVE HISTORY2

  • Switching: 42%
  • Starting: 58%
  • Naive users: 17%

WEIGHT2

  • 22% had BMI 30-35 kg/m2 (mean BMI: 25.8 kg/m2)

ETHNICITY2

  • Hispanic or Latino: 26%
  • Not Hispanic or Latino: 74%

RACE1

  • White: 70%
  • Black: 20%
  • Asian: 5%
  • American Indian or Alaskan Native: 1%
  • Native Hawaiian or Pacific Islander: 0.4%
  • Other: 4%
View Safety Results
Contact Medical Affairs

Phase III data: Results from a large and
inclusive trial program

Contraceptive efficacy

98%

NEXTSTELLIS was 98% effective in preventing pregnancy (Pearl index: 2.65).1,2

Effective across a range of body weights

 

NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m2. In females with BMI ≥ 30 kg/m2, decreasing effectiveness may be associated with increasing BMI.1

NEXTSTELLIS delivered bleeding patterns that were similar to a natural predictable menstrual cycle2

NEXTSTELLIS, with its 24/4 monophasic regimen, delivers a predictable bleeding pattern1,2

Scheduled Bleeding

85%

On average, 85% of women experienced regular withdrawal bleeding (range: 82%-87% across cycles). Average duration was 4.5 days2

Unscheduled Bleeding

<2%

<2% of patients experienced unscheduled bleeding-only episodes after cycle 22

Average Duration

<1 day

<1 day of any unscheduled spotting or bleeding on average per cycle after cycle 12

Treatment Discontinuation

2.8%

2.8% of patients withdrew from treatment due to bleeding irregularities2

Discover more information and the benefits of NEXTSTELLIS

Estetrol (E4) Matters NEXTSTELLIS Story Efficacy Safety Dosing & Prescribing FAQ
footer logo

NEXTSTELLIS® and the Silhouette logo are owned by and licensed from ESTETRA SRL © 2023 Mayne Pharma. All rights reserved. 3301 Benson Drive, Raleigh NC 27609. PM-US-NEX-0320 6/23

Our commitment to accessibility

Mayne Pharma is committed to making our website’s content accessible and user friendly to everyone. If you are having difficulty viewing or navigating the content on this website, or notice any content, feature, or functionality that you believe is not fully accessible to people with disabilities, please call our Website Hotline at +1 833 619 1312 or email our team at us.connect@maynepharma.com with “Disabled Access” in the subject line and provide a description of the specific feature you feel is not fully accessible or a suggestion for improvement.

We take your feedback seriously and will consider it as we evaluate ways to accommodate all of our customers and our overall accessibility policies. Additionally, while we do not control such vendors, we strongly encourage vendors of third-party digital content to provide content that is accessible and user friendly.

 

IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS®

IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS® (drospirenone and estetrol tablets 3 mg/14.2 mg)

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

See full prescribing information for complete boxed warning.

  • Females over 35 years old who smoke should not use NEXTSTELLIS
  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

 

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS.

NEXTSTELLIS (drospirenone and estetrol tablets), for oral use
Initial U.S. Approval: 2021

 

INDICATIONS AND USAGE

NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

 

LIMITATIONS OF USE

NEXTSTELLIS may be less effective in females with a BMI ≥30 kg/m2. In females with BMI ≥30 kg/m2, decreasing effectiveness may be associated with increasing BMI.

 

DOSAGE AND ADMINISTRATION

  • Take one tablet by mouth at the same time every day.
  • Take tablets in the order directed on the blister pack.

 

DOSAGE FORMS AND STRENGTHS

NEXTSTELLIS consists of 28 tablets in the following order:

  • 24 pink active tablets each containing drospirenone 3 mg and estetrol 14.2 mg
  • 4 white inert tablets

 

CONTRAINDICATIONS

  • A high risk of arterial or venous thrombotic diseases
  • Current or history of a hormonally-sensitive malignancy (e.g., breast cancer)
  • Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis
  • Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
  • Abnormal uterine bleeding that has an undiagnosed etiology
  • Renal impairment
  • Adrenal insufficiency

 

WARNINGS AND PRECAUTIONS

  • Thromboembolic Disorders and Other Vascular Problems: Stop NEXTSTELLIS if a thrombotic or thromboembolic event occurs. Start no earlier than 4 weeks after delivery. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors.
  • Hyperkalemia: Check serum potassium concentration during the first NEXTSTELLIS treatment cycle in females on long-term treatment with medications that may increase serum potassium concentration.
  • Hypertension: Monitor blood pressure periodically and stop use if blood pressure rises significantly.
  • Migraine: Discontinue if new, recurrent, persistent, or severe migraines occur.
  • Hormonally-Sensitive Malignancy: Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed.
  • Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.
  • Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia.
  • Gallbladder Disease and Cholestasis: Consider discontinuing NEXTSTELLIS in females with symptomatic gallbladder or cholestatic disease.
  • Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.

 

ADVERSE REACTIONS

Most common adverse reactions (≥2%): Bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased

 

DRUG INTERACTIONS

  • CYP3A Inducers: May lead to contraceptive failure and/or increase breakthrough bleeding. Avoid concomitant use. If concomitant use is unavoidable, use an alternative or back-up contraceptive method during co-administration and up to 28 days after discontinuation of the CYP3A inducer.
  • See full Prescribing Information for additional clinically significant drug interactions.

 

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Discontinue if pregnancy occurs.
  • Lactation: Advise postpartum females that NEXTSTELLIS can decrease milk production.

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.

See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

BMI=body mass index; COC=combined oral contraceptive; EU=European Union; HDL=high-density lipoprotein; LDL=low-density lipoprotein; LNG=levonorgestrel.

 

 

REFERENCES
1. NEXTSTELLIS [package insert]. Raleigh, NC: Mayne Pharma; April 2021.
2. Data on file. Clinical study report MIT‐Es0001‐C302. Mayne Pharma US. Raleigh, NC.
3. Data on file. Clinical study report MIT‐Es0001‐C301. Mayne Pharma US. Raleigh, NC.
4. Data on file. Clinical study report MIT‐Es0001‐C201. Mayne Pharma US. Raleigh, NC.
5. Data on file. Clinical study report MIT‐Es0001‐C202. Mayne Pharma US. Raleigh, NC.
6. Data on file. Clinical study report MIT‐Es0001‐C202. Mayne Pharma US. Raleigh, NC.
7. Food and Drug Administration. Prescription and over-the-counter drug product list: additions/deletions for prescription drug product list. August 2015. Accessed May 21, 2021. https://www.fda.gov/media/93516/download