Suppression of OvulationPhase 2NCT02626208
Dose Finding Study of Contraceptive Vaginal Ring With Different Estradiol Levels in Combination With Nestorone
A Phase 2 study testing Nestorone®/Estradiol Contraceptive Vaginal Ring in people with Suppression of Ovulation, run by Premier Research at 7 sites in United States.
Trial summary
This clinical trial investigates a new vaginal delivery system made of silicone rubber, containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol (E2). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Suppression of Ovulation
- What is being tested?
- Nestorone®/Estradiol Contraceptive Vaginal Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2016to Mar 2017
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
- Age 18-39 years, inclusive, at the enrollment visit.
- Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception
- Have an intact uterus and both ovaries.
- Able and willing to comply with the protocol and sign an informed consent.
- Consistent use of effective contraception during the preceding cycle (note: women who use oral, transdermal, vaginal, implantable or intrauterine hormonal contraceptives in the preceding cycle must have discontinued at least 7 days prior to start of treatment and not had unprotected intercourse since discontinuing the method).
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- Not at high risk for pregnancy, defined as consistently using a non-hormonal method of contraception (including Copper IUDs); have a surgically sterile male partner with a vasectomy; be abstinent; or be in a same-sex relationship from the start of treatment through study exit (including recovery period).
- Have a negative pregnancy test at the admission visit.
- Have a diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤135 mm Hg after 5 minutes rest in sitting position at the admission visit.
- Willing to abstain from use of non-water based vaginal lubricant during the study.
Who cannot join
- Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
- Not living in the catchment area of the study site.
- Known hypersensitivity to progestins or estrogen.
- Contraindications to combined estrogen-progestin contraceptive use including:
- Thrombophlebitis or thromboembolic disorders.
- Past personal history of deep vein thrombophlebitis or thromboembolic disorders.
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- History of venous thrombosis or embolism in a first-degree relative <55 years of age suggesting familial defect in blood coagulation system.
- History of thrombosis or embolism OR any other personal or family history which in the opinion of the investigator suggests increased risk.
- History of stroke.
- Known or suspected carcinoma of the breast.
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
- Undiagnosed abnormal genital bleeding.
- Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use.
- Hepatic adenomas or carcinomas.
- Known or suspected pregnancy.
- Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women <35 years who smoke 15 cigarettes or more per day must be evaluated by the investigator for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
- History of retinal vascular lesions, unexplained partial or complete loss of vision.
- Headaches with focal neurological symptoms (e.g., migraines with auras).
- Desire to become pregnant during the study.
- Breastfeeding.
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed at screening with a Chlamydia or gonococcus infection may be included in the trial following treatment; partner treatment is also recommended. Subjects with vaginal infection (yeast, trichomonis, or bacterial vaginosis) may be enrolled after treatment. Investigators should make a determination if subjects are at high risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included. In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent.
- A known clinically significant Pap test abnormality, as managed by current local or national guidelines that will require treatment during study participation.
- Known benign or malignant liver tumors; known active liver disease.
- Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer).
- Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
- Known or suspected current alcoholism or drug abuse.
- Elevated serum fasting clinical chemistry values or complete blood count (CBC) values designated clinically significant by the investigator or medically qualified sub-investigator.
- Uncontrolled thyroid disease.
- Known impaired hypothalamic-pituitary-adrenal reserve.
- Body mass index (BMI) >35.
- Use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 9 months prior to enrollment or no spontaneous menses since last injection.
- Use of oral, transdermal, vaginal, implantable or intrauterine contraceptives within 7 days prior to start of the treatment cycle. (Copper IUD is allowable. Levonorgestrel releasing IUD is not allowed.) NOTE: Discontinuation of any of these methods must have been for personal reasons unrelated to the purpose of enrollment in this study.
- Known hypersensitivity to silicone rubber.
- History of toxic shock syndrome.
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
- Planning to undergo major surgery during study participation.
- Severe constipation.
- Use of liver enzyme inducers or inhibitors on a regular basis.
- Known HIV infection.
- Bariatric surgery within the past year prior to enrollment. 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Columbia University
New York, New York, 10032
Eastern Virginia Medical School (EVMS)
Norfolk, Virginia, 23507
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science Unit
Portland, Oregon, 97239
University of California, Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84106
About this study
Official title: A Dose Finding Study to Evaluate Serum Estradiol Levels With Use of Contraceptive Vaginal Rings Releasing Nestorone® and Escalating Doses of Estradiol in Normal Cycling Women
This clinical trial investigates a new vaginal delivery system made of silicone rubber, containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings that contain a fixed dose of NES and escalating doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR for a larger contraceptive efficacy trial.
Read the detailed description
This dose-finding study aims to evaluate serum estradiol levels with use of contraceptive vaginal rings releasing Nestorone® and escalating doses of estradiol in normal cycling women. The primary objective is to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings containing a fixed dose of Nestorone® (NES) and escalating doses of estradiol as the basis for selecting a contraceptive vaginal ring (CVR) dose for a contraceptive efficacy trial. The secondary objectives are to evaluate the effects of three different estradiol doses of a NES- E2 CVR on progesterone levels, bleeding and side effects during one month of use and to evaluate the effects of a hormone-free internal on bleeding patterns. Nestorone serum levels will further be measured as an indication of compliance with the continuous use of the ring.
- Conditions
- Suppression of Ovulation
- Being tested
- Nestorone®/Estradiol Contraceptive Vaginal Ring
- Keywords
- Contraceptive vaginal ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestorone®/Estradiol Contraceptive Vaginal RingDevice
Three arms of contraceptive vaginal rings contain a fixed dose (200 mcg/day) of Nestorone® and escalating doses (75 µg/d, 100 µg/d, or 200 µg/d /day) of estradiol
| Study group | Role | What they receive |
|---|---|---|
| Nestorone®/ Estradiol 75 | Experimental | Device: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 75 ug/day of estradiol Receives: Device: Nestorone®/Estradiol Contraceptive Vaginal Ring |
| Nestorone®/Estradiol 100 | Experimental | Device: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 100 ug/day of estradiol Receives: Device: Nestorone®/Estradiol Contraceptive Vaginal Ring |
| Nestorone®/ Estradiol 200 | Experimental | Device: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 200 ug/day of estradiol Receives: Device: Nestorone®/Estradiol Contraceptive Vaginal Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum estradiol (E2) levels of three different contraceptive vaginal rings
Measured: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Secondary outcomes (3)
Change in progesterone levels
Measured: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Vaginal bleeding- amount and frequency
Measured: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Adverse event
Measured: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suppression of OvulationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premier Research
- Sponsor type
- University, hospital or other
- Collaborators
- Population Council, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Diana Blithe, MD, Study chair, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626208
- Sponsor's protocol ID
- CCN012A
- Status last verified
- Aug 2017
- First submitted
- 10 Nov 2015
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study to Evaluate Serum Estradiol Levels With Use of Contraceptive Vaginal Rings Releasing Nestorone® and Escalating Doses of Estradiol in Normal Cycling Women
- ClinicalTrials.gov ID
- NCT02626208
- Acronym / sponsor ID
- CCN012A
- Conditions
- Suppression of Ovulation
- Keywords
- Contraceptive vaginal ring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Premier ResearchUniversity, hospital or other
- Collaborators
- Population Council, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Dec 2015 (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.
This clinical trial investigates a new vaginal delivery system made of silicone rubber, containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings that contain a fixed dose of NES and escalating doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR for a larger contraceptive efficacy trial.
Detailed description
This dose-finding study aims to evaluate serum estradiol levels with use of contraceptive vaginal rings releasing Nestorone® and escalating doses of estradiol in normal cycling women. The primary objective is to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings containing a fixed dose of Nestorone® (NES) and escalating doses of estradiol as the basis for selecting a contraceptive vaginal ring (CVR) dose for a contraceptive efficacy trial. The secondary objectives are to evaluate the effects of three different estradiol doses of a NES- E2 CVR on progesterone levels, bleeding and side effects during one month of use and to evaluate the effects of a hormone-free internal on bleeding patterns. Nestorone serum levels will further be measured as an indication of compliance with the continuous use of the ring.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nestorone®/ Estradiol 75 | Experimental | Device: Nestorone®/Estradiol Contraceptive Vaginal RingDevice: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 75 ug/day of estradiol |
| Nestorone®/Estradiol 100 | Experimental | Device: Nestorone®/Estradiol Contraceptive Vaginal RingDevice: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 100 ug/day of estradiol |
| Nestorone®/ Estradiol 200 | Experimental | Device: Nestorone®/Estradiol Contraceptive Vaginal RingDevice: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 200 ug/day of estradiol |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
- Age 18-39 years, inclusive, at the enrollment visit.
- Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception
- Have an intact uterus and both ovaries.
- Able and willing to comply with the protocol and sign an informed consent.
Key exclusion criteria (40 listed)
- Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
- Not living in the catchment area of the study site.
- Known hypersensitivity to progestins or estrogen.
- Contraindications to combined estrogen-progestin contraceptive use including:
- Desire to become pregnant during the study.
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 |
|---|---|---|
| Nestorone®/Estradiol Contraceptive Vaginal RingThree arms of contraceptive vaginal rings contain a fixed dose (200 mcg/day) of Nestorone® and escalating doses (75 µg/d, 100 µg/d, or 200 µg/d /day) of estradiol | Device | Nestorone®/ Estradiol 200, Nestorone®/ Estradiol 75, Nestorone®/Estradiol 100 |
Primary outcome
Change in serum estradiol (E2) levels of three different contraceptive vaginal rings
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
3 secondary outcomes
Change in progesterone levels
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Vaginal bleeding- amount and frequency
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Adverse event
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
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 15 Aug 2017.
- The National Institute on Child Health and Human Development (NICHD) supports research on male and female contraception and conducts clinical trials of new contraceptive drugs and devices.Link provided by the sponsor.
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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.
Diana Blithe, MD study chair
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
7 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 Nestorone®/Estradiol Contraceptive Vaginal Ring in people with Suppression of Ovulation, run by Premier Research at 7 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 10 inclusion and 40 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Change in serum estradiol (E2) levels of three different contraceptive vaginal rings (time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2017.