Focus: Estrogen-free Oral ContraceptionPhase 2CCN013NCT01953679

Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days

A Phase 2 study testing Ulipristal Acetate in people with Focus: Estrogen-free Oral Contraception, run by Premier Research at 10 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

To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg. 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: Focus: Estrogen-free Oral Contraception
What is being tested?: Ulipristal Acetate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 10 sitesUnited States
Study dates: Mar 2014to Nov 2015
Phase: Phase 2
Are there results?: None posted in the registry

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

Women between 18 and 35 years old.
In good health, with regular menstrual cycles that occur every 21-35 days.
If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles (3 menses) prior to screening.
If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening.
No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment.
No use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 6 months prior to screening unless the subject has returned to normal menses since last injection.

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Have a negative urine pregnancy test at the admission visit.
Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, barrier method with every act of intercourse until the time of study exit OR have a surgically sterile male partner with a vasectomy, must have undergone previous tubal ligation, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
In the opinion of the investigator, willing and able to follow all study requirements, including use of the study product and willing to record requested information on a daily diary.
Understand and sign an IRB approved inform consent form prior to screening activities (including fasting blood draws).
Will have diastolic blood pressure (BP) ≤95 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in sitting position.
BMI < 40 kg/m2 and not having previously undergone bariatric surgery.
Agree not to participate in any other clinical trials during the course of this study.

Who cannot join

Women less than 18 and older than 35 years old.
Women with menstrual cycle length of less than 21 or more than 35 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days.
If subject is postpartum or post-abortal (with abortion in second trimester) and not had two normal menstrual cycles (3 menses) prior to screening.
If subject had an abortion in the first trimester and not had at least one menstrual cycle (two menses) prior to screening.
Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test.
Unwilling to use a barrier method with every act of intercourse until study exit OR not have a surgically sterile male partner with a vasectomy, not have undergone previous tubal ligation, not abstinent, or not in a same-sex relationship from the control period through study exit (including recovery period).

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Women planning pregnancy within their months of study participation.
Currently breast-feeding or within 30 days of discontinuing breast feeding, unless the woman has already had a menses following discontinuation of breast feeding.
Current use of an IUD, or other hormonal contraception within last complete menstrual cycle prior to screening.
Use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 6 months prior to screening without the subject returning to normal menses since last injection.
Undiagnosed abnormal genital bleeding.
Known hypersensitivity to the active substance UPA or any of the excipients of the study treatment.
Anomalies in endometrial appearance, TVUS or safety labs done at screening visit recognized as clinically significant by the investigator.
Subject with a previous history of endometrial ablation.
A clinically significant Pap test abnormality, as managed by current local or national guidelines. Women with a current abnormal Pap (within the last eighteen months):
In accordance with the Bethesda system of classification: smear suggestive of high-grade pre-cancerous lesion(s), including high grade squamous intraepithelial lesions (HGSILs), are excluded; • Women with low grade squamous intraepithelial lesion (LGSIL) or atypical squamous cells of undetermined significance (ASCUS)/high-risk human papillomavirus (HPV) positive, or Atypical squamous cells, cannot rule out a high grade lesion (ASC-H) may participate if further evaluated with colposcopy and biopsy determines no evidence of a lesion with a severity greater than cervical intraepithelial neoplasia (CIN) I. • Women with a biopsy finding of CIN I should have follow-up for this finding per standard of care; women are excluded if treatment is indicated.
In accordance with other Pap class systems:
Women with high grade dysplasia are excluded.
Women with atypical glandular cells of undetermined significance (AGUS) are excluded.
Women with low grade dysplasia or CIN I interpretation on Pap test may participate following exclusion of a high grade lesion by colposcopic evaluation based on Investigator discretion and provided there is appropriate follow up in accordance with local standards.
Has any of the following known contraindication to progestin-only oral contraceptive (OC):
History or existing breast cancer, or other hormone sensitive neoplasia;
Current and history of ischemic heart disease or stroke while pregnant or taking birth control pills;
Acute deep venous thrombosis or pulmonary embolism;
Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies;
Benign and malignant liver tumors;
Severe (decompensated) cirrhosis.
Hereditary galactose intolerance, Lapp lactase deficiency , or glucose-galactose malabsorption.
Known or suspected alcoholism or drug abuse.
Known HIV infection.
Smoking 15 cigarettes or more per day must be evaluated by the investigator or medically qualified designee for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism.
Current or past deep vein thrombophlebitis or thromboembolic disorders.
Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication.
Concomitant use of medication thought to interact with UPA (per SPCs):
CYP3A4 inducers (rifampin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St John's Wort, topiramate),
Other hormonal contraceptives including emergency contraception.
Use of any medications that can interfere with the metabolism of hormone contraceptives, antibiotics that can interfere with metabolism of hormone contraceptives, and any drugs designated by the FDA as Pregnancy Category D or X.
Current participation in any other trial of an investigational medicine or device or participation in the past three months before start of first treatment phase.
Headaches with focal neurological symptoms only.
Have diastolic blood pressure (BP) >95 mm Hg and systolic BP >145 mm Hg after 5 minutes in sitting position.
Hypertensive subjects who are treatment controlled and in the judgment of the investigator are a good candidate require a waiver for participation.
BMI ≥40 kg/m² or having previously undergone bariatric surgery.
Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
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Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of Colorado - Denver Anschutz Medical Campus
Aurora, Colorado, 80045
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati-Holmes Hospital
Cincinnati, Ohio, 45267
California Family Health Council
Los Angeles, California, 90010
NYU School of Medicine
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Eastern Virgina Medical School
Norfolk, Virginia, 23507
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Oregon Health and Sciences University
Portland, Oregon, 97239
University of California, San Francisco
San Francisco, California, 94110

Other trials in United States

About this study

Official title: A Phase IIb Randomized, Double Blind, Comparative Study to Assess the Efficacy, Safety, Tolerability and Inhibition of Ovulation of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days

To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.

Conditions: Focus: Estrogen-free Oral Contraception
Being tested: Ulipristal Acetate

What participants receive

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

Ulipristal AcetateDrug

Study groups in NCT01953679
Study group	Role	What they receive
5mg UPA	Active comparator	Continuous regimen of oral daily 5 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval. Receives: Drug: Ulipristal Acetate
10mg UPA	Active comparator	Continuous regimen of oral daily 10 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval. Receives: Drug: Ulipristal Acetate

What is being measured

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

Ovulation inhibition
- Two consecutive serum progesterone values ≥10nMol/L (3ng/mL) within a four day window;
- A follicle ≥13 mm followed by a single serum progesterone value ≥10nMol/L (3ng/mL) without a second high progesterone level but with follicle disappearance, suggestive of follicular rupture.
Measured: Approximately 6.5 months

Secondary outcomes (4)

Bleeding profile
Total number of bleeding and spotting days per 28 day and 84 day interval, menses duration and intensity, bleeding-related AEs, hematocrit levels, subject's acceptability of treatment.
Measured: Approximately 6.5 months
Follicle growth and rupture
Follicle growth (≥13 mm and ≥15 mm) and rupture assessed using transvaginal ultrasound (TVUS) twice weekly during the 84 day treatment.
Measured: Approximately 6.5 months
Endometrial safety
1. Endometrial thickness by TVUS
2. Endometrial biopsies during the Baseline cycle at Visit BL2 (Proliferative phase), on Treatment at Visit 22 ± 1 visit (between days 70 -80) OR 7-10 days following any suspected ovulation that occurs after the first 28 days of treatment, and at the end of the recovery period after two full washout cycles during day 7 following start of second menses (Proliferative phase).
Measured: Approximately 6.5 months
Overall subject satisfaction and safety
Measured: Approximately 6.5 months

Timeline

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

Mar 2014Nov 2015

First posted1 Oct 2013 (estimated)
Study startMar 2014
Primary completionAug 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Focus: Estrogen-free Oral ContraceptionStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01953679
Sponsor's protocol ID: CCN013
Acronym: CCN013
Status last verified: Feb 2016
First submitted: 23 Aug 2013
Last updated: 22 Feb 2016
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb Randomized, Double Blind, Comparative Study to Assess the Efficacy, Safety, Tolerability and Inhibition of Ovulation of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days
ClinicalTrials.gov ID: NCT01953679
Acronym / sponsor ID: CCN013 / CCN013
Conditions: Focus: Estrogen-free Oral Contraception
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Premier ResearchUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Mar 2014
Primary completion: Aug 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 1 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
5mg UPA	Active comparator	Drug: Ulipristal AcetateContinuous regimen of oral daily 5 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval.
10mg UPA	Active comparator	Drug: Ulipristal AcetateContinuous regimen of oral daily 10 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval.

Who may qualify

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

Key inclusion criteria (13 listed)

Women between 18 and 35 years old.
In good health, with regular menstrual cycles that occur every 21-35 days.
No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment.
Have a negative urine pregnancy test at the admission visit.
Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, barrier method with every act of intercourse until the time of study exit OR have a surgically sterile male partner with a vasectomy, must have undergone previous tubal ligation, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).

Key exclusion criteria (44 listed)

Women less than 18 and older than 35 years old.
Women with menstrual cycle length of less than 21 or more than 35 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days.
Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test.
Unwilling to use a barrier method with every act of intercourse until study exit OR not have a surgically sterile male partner with a vasectomy, not have undergone previous tubal ligation, not abstinent, or not in a same-sex relationship from the control period through study exit (including recovery period).
Women planning pregnancy within their months of study participation.

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
Ulipristal Acetate	Drug	10mg UPA, 5mg UPA

Primary outcome

Ovulation inhibition
Time frame: Approximately 6.5 months
* Two consecutive serum progesterone values ≥10nMol/L (3ng/mL) within a four day window; * A follicle ≥13 mm followed by a single serum progesterone value ≥10nMol/L (3ng/mL) without a second high progesterone level but with follicle disappearance, suggestive of follicular rupture.

4 secondary outcomes

Bleeding profile
Time frame: Approximately 6.5 months
Follicle growth and rupture
Time frame: Approximately 6.5 months
Endometrial safety
Time frame: Approximately 6.5 months
Overall subject satisfaction and safety
Time frame: Approximately 6.5 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ulipristal Acetate in people with Focus: Estrogen-free Oral Contraception, run by Premier Research at 10 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 13 inclusion and 44 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ovulation inhibition (time frame: Approximately 6.5 months). 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 NCT01953679.

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 22 Feb 2016.