ContraceptionPhase 1NCT04272008
The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
A Phase 1 study testing Segesterone Acetate and Ethinyl Estradiol and Tampon in people with Contraception, run by TherapeuticsMD at 2 sites in 2 countries.
Trial 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). 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
- Contraception
- What is being tested?
- Segesterone Acetate and Ethinyl Estradiol and Tampon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Mar 2020to 8 Jun 2021
- 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
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- Women who smoke 15 cigarettes or more per day must be evaluated by the Principal Investigator (PI) for inclusion based on risk factors that would increase their risk for cardiovascular disease and thromboembolism, eg, lipid levels, glucose level, blood pressure (BP), body mass index (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.
- Has a Type D personality type as assessed by the DS14 test (Standard Assessment of Negative Affectivity, Social Inhibition and Type D Personality).
- 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 BP > 85 mm Hg and/or systolic BP > 135 mm Hg after 5 to 10 minutes rest (at Screening).
- Known or suspected alcoholism or drug abuse within their lifetime. aa. Elevated serum fasting clinical chemistry values or complete blood count (CBC) values designated clinically significant by the Investigator and/or medically qualified Sub-Investigator.
- bb. Screening hemoglobin levels less than 12.5 g/dL or hematocrit less than 38%.
- cc. Participation in another clinical trial involving an investigational drug within the last 30 days (prior to Screening). dd. BMI > 29 kg/m2. ee. Use of liver enzyme inducers on a regular basis. ff. Use of monthly injectable contraceptives, unless suspended 2 months before initiation of the treatment. Use of Depo-Provera® [depot medroxyprogesterone acetate] unless suspended 9 months before treatment.
- gg. Current use of implanted hormonal contraceptives, including Mirena® [progestin containing intrauterine system], Jadelle®, Norplant®, Implanon® or Nexplanon (if now available in the USA). hh. Known HIV, Hepatitis B or Hepatitis C infection. ii. History of frequent vaginal infections in the opinion of the PI. jj. Use of any oral medications or supplements during the trial that could interfere with the metabolism of the contraceptive hormones. Use of any vaginal preparations during Treatment Cycle 1 or Treatment Cycle 2. Use of any medication during the study must be reviewed and approved by the Medical Monitor
- Women using non-hormonal intrauterine devices are permitted to enroll in the study.
- Participants using any of the implanted hormonal methods who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Pennsylvania Women's Health Clinical Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Study to Evaluate the Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
This study will evaluate the effect of Annovera and tampon co-usage on the pharmacokinetics (PK) of segesterone acetate (SA) and ethinyl estradiol (EE).
Read the detailed description
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.
- Conditions
- Contraception
- Being tested
- Segesterone Acetate and Ethinyl Estradiol, Tampon
- Keywords
- tampon, vaginal ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segesterone Acetate and Ethinyl EstradiolDrug
Also called Annovera
Annovera taken alone
TamponOther
Annovera with tampon use
| Study group | Role | What they receive |
|---|---|---|
| Annovera (alone) | Active comparator | Annovera without tampon use Receives: Drug: Segesterone Acetate and Ethinyl Estradiol |
| Annovera with tampon use | Active comparator | Annovera with tampon use Receives: Drug: Segesterone Acetate and Ethinyl Estradiol; Other: Tampon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
AUC for 72 hours
Measured: Days 2 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start6 Mar 2020
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- TherapeuticsMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Mirkin, MD, Study chair, TherapeuticsMD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272008
- Sponsor's protocol ID
- ANNOV3454-3 PMR
- Status last verified
- Oct 2021
- First submitted
- 13 Feb 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
- ClinicalTrials.gov ID
- NCT04272008
- Acronym / sponsor ID
- ANNOV3454-3 PMR
- Conditions
- Contraception
- Keywords
- tampon, vaginal ring
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- TherapeuticsMDIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- 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 study will evaluate the effect of Annovera and tampon co-usage on the pharmacokinetics (PK) of segesterone acetate (SA) and ethinyl estradiol (EE).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Annovera (alone) | Active comparator | Drug: Segesterone Acetate and Ethinyl EstradiolAnnovera without tampon use |
| Annovera with tampon use | Active comparator | Drug: Segesterone Acetate and Ethinyl Estradiol, Other: TamponAnnovera with tampon use |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
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 |
|---|---|---|
| Segesterone Acetate and Ethinyl EstradiolAlso: AnnoveraAnnovera taken alone | Drug | Annovera (alone), Annovera with tampon use |
| TamponAnnovera with tampon use | Other | Annovera with tampon use |
Primary outcome
The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 3)
Time frame: Days 2 to 3
AUC for 24 hours
1 secondary outcome
The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 5)
Time frame: Days 2 to 5
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 29 Oct 2021.
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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.
Sebastian Mirkin, MD study chair
TherapeuticsMD
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Segesterone Acetate and Ethinyl Estradiol and Tampon in people with Contraception, run by TherapeuticsMD at 2 sites in 2 countries.
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 32 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 3) (time frame: Days 2 to 3). 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 29 Oct 2021.