The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol

NCT04272008 | Completed Phase 1 FDA Drug

• 1 other identifier: ANNOV3454-3 PMR
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 2

Brief Summary

This study will evaluate the effect of Annovera and tampon co-usage on the pharmacokinetics (PK) of segesterone acetate (SA) and ethinyl estradiol (EE).

Conditions

Contraception

Keywords

tampon; vaginal ring

Outcome Measures

Primary Outcomes (1)

• The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 3)

  AUC for 24 hours

  Days 2 to 3

Secondary Outcomes (1)

• The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 5)

  Days 2 to 5

Study Arms (2)

Annovera (alone)

ACTIVE COMPARATOR

Annovera without tampon use

Drug: Segesterone Acetate and Ethinyl Estradiol

Annovera with tampon use

ACTIVE COMPARATOR

Annovera with tampon use

Drug: Segesterone Acetate and Ethinyl Estradiol; Other: Tampon

Interventions

Segesterone Acetate and Ethinyl Estradiol DRUG

Annovera taken alone

Also known as: Annovera

Annovera (alone); Annovera with tampon use

Tampon OTHER

Annovera with tampon use

Annovera with tampon use

Eligibility Criteria

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

You may qualify if:

• All of the following criteria must be met for the participants to be eligible for the study:
• Healthy women, sterile or at risk of becoming pregnant, inclusive of ages 18 to 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 to 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, eg, live within the study site catchment area or within a reasonable distance from the study site.
• Willing to use oral contraception for one month prior to the initial insertion of Annovera.
• Willing to abstain from tampon use except during the prescribed time of the trial.
• Willing to abstain from sexual intercourse during tampon use.
• Signed informed consent prior to entry into the trial.
• Upper age limit based on normal ovarian changes (ovarian reserve) prevalent in women with advancing age (\> 35 years of age) that may alter patterns of follicle development and/or confound interpretations of data regarding patterns of follicle development

You may not qualify if:

• Contraindications for enrollment will be the same as those for use of CHCs and additional criteria important to the objectives of this study and include:
• 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. Participants 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 participants are at high risk for reinfection, eg, multiple sex partners, untreated partner, and whether such participants can be included.
• History of pelvic inflammatory disease since the participant'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 Papanicolaou smear (Pap smear) suggestive of high-grade pre-cancerous lesion (s), including high grade squamous intraepithelial lesion.
• 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.

Sponsors & Collaborators

• TherapeuticsMD: lead

Study Sites (2)

University of Pennsylvania Women's Health Clinical Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Syneos Health

Québec, Quebec, G1P OA2, Canada

Location

MeSH Terms

Interventions

segesterone acetate and ethinyl estradiol vaginal system

Study Officials

• Sebastian Mirkin, MD

  TherapeuticsMD

  STUDY CHAIR

Study Design

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

Model Details: This is an open label, randomized, crossover PK study. Participants will be randomized to one of two treatment sequences. Each treatment sequence consists of two cycles of treatment - one with tampon use and one without tampon use. Tampon use will occur on Days 2 to 5 of contraceptive vaginal system (CVS) use and a new CVS will be used for each treatment cycle. Before starting Annovera use, each subject will use a combined oral contraceptive (COC) for one cycle.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: March 6, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (1); CA (1)