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

NCT02215395 | Completed Phase 1

• 1 other identifier: 571
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Antifungal Drug Adverse Reaction

Keywords

Nestorone; miconazole nitrate

Outcome Measures

Primary Outcomes (1)

• 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

  Week 12

Study Arms (1)

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.

Drug: NES/EE CVR

Interventions

NES/EE CVR DRUG

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)

Also known as: Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)

CVR treatment cycle

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Population Council: lead

Study Sites (1)

QPS Bio-Kinetic

Springfield, Missouri, 65802, United States

Location

Related Publications (1)

• 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.

  PMID: 29097225 DERIVED

MeSH Terms

Interventions

ST 1435; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dennis Morrison, MD

  QPS-Biokinetic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: August 13, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

US (1)