HealthyPhase 3NCT00544882

A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

A Phase 3 study testing DR-1021, Mircette® and Kariva® in people with Healthy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021. Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: DR-1021, Mircette® and Kariva®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 4 sitesUnited States
Study dates: 31 Oct 2007to 31 Mar 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Premenopausal
Weight <200 lbs
Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
Others as dictated by protocol

Who cannot join

Any contraindication to the use of oral contraceptives
Breast feeding
Smoking > 10 cigarettes per day
Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])
Others as dictated by protocol

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Lawrenceville, New Jersey, 08648
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Investigational Site
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.

Read the detailed description

Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.

Conditions: Healthy
Being tested: DR-1021, Mircette®, Kariva®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DR-1021Drug
Also called desogestrel/ethinyl estradiol
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
Mircette®Drug
Also called desogestrel/ethinyl estradiol
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Kariva®Drug
Also called desogestrel/ethinyl estradiol
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Study groups in NCT00544882
Study group	Role	What they receive
DR-1021	Experimental	After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). Receives: Drug: DR-1021; Drug: Kariva®
Mircette	Active comparator	After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). Receives: Drug: Mircette®; Drug: Kariva®

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Estradiol Levels by Cycle Day
Levels of estradiol were measured throughout the study from blood samples.
Measured: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Measured: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Serum Inhibin-B Levels by Cycle Day
Levels of inhibin-B were measured throughout the study from blood samples.
Measured: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.

Secondary outcomes (6)

Percentage of Follicles Greater Than 5 mm in Diameter
Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).
Measured: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.
Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size
The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.
Measured: Cycle 2, Days 1-20 and Cycle 2, Days 21-28
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.
Measured: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.
Measured: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.
Measured: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.
Measured: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 200731 Mar 2008

First posted16 Oct 2007 (estimated)
Study start31 Oct 2007
Primary completion31 Mar 2008
Study completion31 Mar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00544882
Sponsor's protocol ID: DR-DSG-302
Status last verified: Nov 2021
First submitted: 12 Oct 2007
Last updated: 18 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021
ClinicalTrials.gov ID: NCT00544882
Acronym / sponsor ID: DR-DSG-302
Conditions: Healthy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 31 Oct 2007 (actual)
Primary completion: 31 Mar 2008 (actual)
Study completion: 31 Mar 2008 (actual)
First posted: 16 Oct 2007 (estimated)
Results: Posted 10 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DR-1021	Experimental	Drug: DR-1021, Drug: Kariva®After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
Mircette	Active comparator	Drug: Mircette®, Drug: Kariva®After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Premenopausal
Weight <200 lbs
Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
Others as dictated by protocol

Key exclusion criteria (5 listed)

Any contraindication to the use of oral contraceptives
Breast feeding
Smoking > 10 cigarettes per day
Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])
Others as dictated by protocol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DR-1021Also: desogestrel/ethinyl estradiolTwenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.	Drug	DR-1021
Mircette®Also: desogestrel/ethinyl estradiolTwenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.	Drug	Mircette
Kariva®Also: desogestrel/ethinyl estradiolTwenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.	Drug	DR-1021, Mircette

Primary outcome

Serum Estradiol Levels by Cycle Day
Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Levels of estradiol were measured throughout the study from blood samples.
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Serum Inhibin-B Levels by Cycle Day
Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Levels of inhibin-B were measured throughout the study from blood samples.

6 secondary outcomes

Percentage of Follicles Greater Than 5 mm in Diameter
Time frame: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.
Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size
Time frame: Cycle 2, Days 1-20 and Cycle 2, Days 21-28
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

Results and safety

Results posted to the registry on 10 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Run-In Cycle - All Enrolled	61	58
DR-1021	0	0
Mircette	0	0

Primary outcome: Serum Estradiol Levels by Cycle Day

Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.. Median (Full Range). Unit: pg/mL

Measure	DR-1021 n = 28	Mircette n = 28
Cycle 2 - Day 2 (n=28, 28)	47.00 (15.0 to 361.0)	51.50 (6.0 to 322.0)
Cycle 2 - Day 4 (n=28, 28)	62.50 (1.0 to 613.0)	34.50 (1.0 to 423.0)
Cycle 2 - Day 6 (n=27, 27)	43.00 (1.0 to 579.0)	29.00 (1.0 to 274.0)
Cycle 2 - Days 19-20 (n=26, 28)	19.00 (1.0 to 152.0)	20.50 (1.0 to 327.0)
Cycle 2 - Day 23 (n=27, 28)	24.00 (1.0 to 204.0)	19.00 (1.0 to 159.0)
Cycle 2 - Day 24 (n=25, 28)	25.00 (1.0 to 289.0)	26.50 (1.0 to 169.0)
Cycle 2 - Day 25 (n=27, 28)	24.00 (1.0 to 169.0)	26.00 (1.0 to 225.0)
Cycle 2 - Day 27 (n=25, 28)	30.00 (1.0 to 233.0)	20.00 (1.0 to 213.0)

DR-1021 vs Mircette: p = 0.6346, Wilcoxon (Mann-Whitney)
DR-1021 vs Mircette: p = 0.2757, Wilcoxon (Mann-Whitney)
DR-1021 vs Mircette: p = 0.1321, Wilcoxon (Mann-Whitney)

Population analysed: Intent-to-treat population with available data at each time point (as indicated by n).

Primary outcome: Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day

Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.. Median (Full Range). Unit: mIU/mL

Measure	DR-1021 n = 28	Mircette n = 28
Cycle 2 - Day 2 (n=28, 28)	4.00 (2.3 to 9.7)	4.00 (1.2 to 7.1)
Cycle 2 - Day 4 (n=28, 28)	3.55 (1.2 to 9.5)	3.70 (0.9 to 28.8)
Cycle 2 - Day 6 (n=28, 27)	3.70 (0.4 to 8.5)	3.50 (0.2 to 14.9)
Cycle 2 - Days 19-20 (n=26, 28)	1.45 (0.2 to 5.7)	1.55 (0.2 to 8.1)
Cycle 2 - Day 23 (n=27, 28)	2.70 (0.2 to 6.3)	2.35 (0.2 to 6.3)
Cycle 2 - Day 24 (n=25, 28)	2.80 (0.2 to 8.0)	3.70 (0.2 to 8.4)
Cycle 2 - Day 25 (n=27, 28)	2.90 (0.2 to 8.0)	3.90 (0.2 to 11.3)
Cycle 2 - Day 27 (n=25, 28)	3.70 (0.2 to 9.6)	3.90 (0.3 to 8.3)

DR-1021 vs Mircette: p = 0.8892, Wilcoxon (Mann-Whitney)
DR-1021 vs Mircette: p = 0.7678, Wilcoxon (Mann-Whitney)
DR-1021 vs Mircette: p = 0.5782, Wilcoxon (Mann-Whitney)

Population analysed: Intent-to-treat population with available data at each time point (as indicated by n).

Primary outcome: Serum Inhibin-B Levels by Cycle Day

Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.. Median (Full Range). Unit: pg/mL

Measure	DR-1021 n = 28	Mircette n = 28
Cycle 2 - Day 2 (n=28, 28)	92.30 (3.5 to 157.9)	99.00 (37.0 to 460.7)
Cycle 2 - Day 4 (n=28, 28)	42.80 (13.3 to 128.9)	64.45 (15.9 to 197.0)
Cycle 2 - Day 6 (n=28, 27)	46.35 (3.5 to 186.9)	41.20 (12.7 to 207.5)
Cycle 2 - Days 19-20 (n=26, 28)	23.15 (3.5 to 203.4)	28.85 (3.5 to 159.3)
Cycle 2 - Day 23 (n=27, 28)	28.10 (3.5 to 159.3)	32.15 (3.5 to 170.8)
Cycle 2 - Day 24 (n=25, 28)	36.80 (3.5 to 142.8)	55.00 (3.5 to 200.0)
Cycle 2 - Day 25 (n=27, 28)	35.20 (3.5 to 148.5)	62.30 (3.5 to 156.7)
Cycle 2 - Day 27 (n=25, 28)	39.60 (3.5 to 152.6)	49.20 (3.5 to 127.6)

DR-1021 vs Mircette: p = 0.0979, Wilcoxon (Mann-Whitney)
DR-1021 vs Mircette: p = 0.0629, Wilcoxon (Mann-Whitney)
DR-1021 vs Mircette: p = 0.8464, Wilcoxon (Mann-Whitney)

Population analysed: Intent-to-treat population with available data at each time point (as indicated by n).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DR-1021	0 of 28 (0%)	7 of 28 (25%)	Not reported
Mircette	1 of 28 (3.6%)	7 of 28 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duramed Protocol Chair study chair

Duramed Research, Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DR-1021, Mircette® and Kariva® in people with Healthy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Estradiol Levels by Cycle Day (time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00544882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.