Antifungal Drug Adverse ReactionPhase 1NCT02215395
An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women
A Phase 1 study testing NES/EE CVR in people with Antifungal Drug Adverse Reaction, run by Population Council at 1 site in United States.
Trial summary
To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream). 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
- Antifungal Drug Adverse Reaction
- What is being tested?
- NES/EE CVR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 1
- 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
- Healthy women, inclusive of ages 18-35* years at the enrollment visit
- Intact uterus and both ovaries
- Prior history of regular menstrual cycles that usually occur every 28 ± 7 days when not using hormonal contraception; if postpartum or post-abortal, history of regular menstrual cycles of 21-35 days in length and resumption of at least one cycle with a cycle length consistent with her past cycles
- In the opinion of the investigator, able to comply with the protocol, e.g. live within the study site catchment area or within a reasonable distance from the study site
- May be sterilized or at risk of becoming pregnant
- Willing to use a non-hormonal method of contraception for one month prior to the initial insertion of the NES/EE CVR and the one month washout period
- Willing to abstain from sexual intercourse during the miconazole nitrate treatment period(s)
- Signed informed consent prior to entry into the trial
Who cannot join
- Known hypersensitivity to estrogens or progestins
- Pregnant, trying to become pregnant, or breastfeeding
- Known hypersensitivity to silicone rubber
- Undiagnosed abnormal vaginal bleeding
- Undiagnosed vaginal discharge, 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. 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
- History of pelvic inflammatory disease since the subject's last pregnancy
Show all 34Show fewer
- History of toxic shock syndrome
- In accordance with the Bethesda system of classification: Women with a current (within the last 20 months) abnormal Pap smear suggestive of high-grade pre-cancerous lesion (s), including HGSIL
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring
- Women planning to undergo major surgery during the trial
- Women who smoke 15 cigarettes or more per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for cardiovascular disease and thromboembolism, e.g., lipid levels, glucose level, BP, BMI, family history of cardiovascular disease at a young age
- Current or past thrombophlebitis or thromboembolic disorders
- History of venous thrombosis or embolism in a first-degree relative, <55 years of age suggesting a familial defect in the blood coagulation system, which in the opinion of the PI, suggests that use of a hormonal contraceptive could pose a significant risk
- Cerebrovascular or cardiovascular disease
- History of retinal vascular lesions, unexplained partial or complete loss of vision
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Past history of any other carcinoma unless in remission for more than five years
- Current or history of medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by the use of a hormonal contraceptive
- Headaches with focal neurological symptoms
- Severe constipation in the opinion of the investigator
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid use
- Benign or malignant liver tumors; active liver disease
- Diastolic blood pressure (BP) >85 mm Hg and/or systolic BP >135 mm Hg after 5-10 minutes rest (at screening)
- Known or suspected alcoholism or drug abuse within their lifetime
- Elevated serum fasting clinical chemistry values or complete blood count (CBC) values designated clinically significant by the investigator and/or medically qualified sub-investigator
- Screening hemoglobin levels less than 12.5 g/dL or hematocrit less than 38%.
- Participation in another clinical trial involving an investigational drug within the last 30 days (prior to screening)
- BMI >29
- Use of liver enzyme inducers on a regular basis
- Use of monthly injectable contraceptives, unless suspended 2 months before initiation of the treatment. Use of Depo-Provera [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment
- Current use of implanted hormonal contraceptives, including Mirena [progestin containing intrauterine system (IUS)], Jadelle, Norplant, Implanon or Nexplanon (if now available in the USA).**
- Known HIV, Hepatitis B or Hepatitis C infection
- History of frequent vaginal infections in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication (Miconazole Nitrate) on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring Releasing a Daily Dose of 150 ug of NES and 15 ug of EE
To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).
- Conditions
- Antifungal Drug Adverse Reaction
- Being tested
- NES/EE CVR
- Keywords
- Nestorone, miconazole nitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NES/EE CVRDrug
Also called Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)
Concurrent administration of vaginal antimycotic medication (Miconazole Nitrate) on the pharmacokinetics of Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)
| Study group | Role | What they receive |
|---|---|---|
| CVR treatment cycle | Experimental | Women who meet all inclusion and no exclusion criteria will be randomized to the first treatment cycle with the CVR alone followed by the second treatment cycle with the CVR and miconazole (one of three dosing regimens) or the first treatment cycle with the CVR and miconazole followed by the second treatment cycle with the CVR alone. Receives: Drug: NES/EE CVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Drug Interaction of NES/EE CVR and topical anti-fungal medication
To evaluate adverse reactions to a topical anti-fungal medication when used in conjunction with the NES/EE CVR
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antifungal Drug Adverse ReactionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Morrison, MD, Principal investigator, QPS-Biokinetic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215395
- Sponsor's protocol ID
- 571
- Status last verified
- Aug 2017
- First submitted
- 29 May 2014
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Simmons KB, Kumar N, Plagianos M, Roberts K, Hoskin E, Han L, Alami M, Creasy G, Variano B, Merkatz R. Effects of concurrent vaginal miconazole treatment on the absorption and exposure of Nestorone(R) (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring: a randomized, crossover drug-drug interaction study. Contraception. 2018 Mar;97(3):270-276. doi: 10.1016/j.contraception.2017.10.010. Epub 2017 Oct 31.
PubMed 29097225
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
- Phase 1, Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication (Miconazole Nitrate) on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring Releasing a Daily Dose of 150 ug of NES and 15 ug of EE
- ClinicalTrials.gov ID
- NCT02215395
- Acronym / sponsor ID
- 571
- Conditions
- Antifungal Drug Adverse Reaction
- Keywords
- Nestorone, miconazole nitrate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Aug 2014 (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 evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVR treatment cycle | Experimental | Drug: NES/EE CVRWomen who meet all inclusion and no exclusion criteria will be randomized to the first treatment cycle with the CVR alone followed by the second treatment cycle with the CVR and miconazole (one of three dosing regimens) or the first treatment cycle with the CVR and miconazole followed by the second treatment cycle with the CVR alone. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy women, inclusive of ages 18-35* years at the enrollment visit
- Intact uterus and both ovaries
- Prior history of regular menstrual cycles that usually occur every 28 ± 7 days when not using hormonal contraception; if postpartum or post-abortal, history of regular menstrual cycles of 21-35 days in length and resumption of at least one cycle with a cycle length consistent with her past cycles
- In the opinion of the investigator, able to comply with the protocol, e.g. live within the study site catchment area or within a reasonable distance from the study site
- May be sterilized or at risk of becoming pregnant
Key exclusion criteria (34 listed)
- Known hypersensitivity to estrogens or progestins
- Pregnant, trying to become pregnant, or breastfeeding
- Known hypersensitivity to silicone rubber
- Undiagnosed abnormal vaginal bleeding
- Undiagnosed vaginal discharge, 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. 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
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 |
|---|---|---|
| NES/EE CVRAlso: Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)Concurrent administration of vaginal antimycotic medication (Miconazole Nitrate) on the pharmacokinetics of Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR) | Drug | CVR treatment cycle |
Primary outcome
Drug Drug Interaction of NES/EE CVR and topical anti-fungal medication
Time frame: Week 12
To evaluate adverse reactions to a topical anti-fungal medication when used in conjunction with the NES/EE CVR
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.
- Derived from this study: PubMed 29097225Simmons KB, Kumar N, Plagianos M, Roberts K, Hoskin E, Han L, Alami M, Creasy G, Variano B, Merkatz R. Effects of concurrent vaginal miconazole treatment on the absorption and exposure of Nestorone(R) (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring: a randomized, crossover drug-drug interaction study. Contraception. 2018 Mar;97(3):270-276. doi: 10.1016/j.contraception.2017.10.010. Epub 2017 Oct 31.
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.
Dennis Morrison, MD principal investigator
QPS-Biokinetic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NES/EE CVR in people with Antifungal Drug Adverse Reaction, run by Population Council at 1 site 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 8 inclusion and 34 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Drug Drug Interaction of NES/EE CVR and topical anti-fungal medication (time frame: Week 12). 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 NCT02215395, which also lists 1 linked publication.
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.