AzTrials
AzTrials

PregnancyPhase 1NCT02817464

Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle

A Phase 1 study testing TV-46046 - 400 mg/mL and TV-46046 - 200 mg/mL in people with Pregnancy and Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Contraception
What is being tested?
TV-46046 - 400 mg/mL and TV-46046 - 200 mg/mL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
26 Oct 2016to 3 Dec 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • has regular menstrual cycle (24 to 35 days)
  • is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in monogamous relationship with vasectomized partner, or using non-hormonal IUD)
  • is in good general health as determined by a medical history and physical examination
  • is not pregnant and does not have desire to become pregnant in the subsequent 36 months
  • has had a normal mammogram within the last year (for Part 1 only)
  • additional criteria apply, please contact the investigator for more information

Who cannot join

  • has hypertension:
  • systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg
  • vascular disease
  • has current or history of ischemic heart disease
  • has history of stroke
  • has history of thromboembolic event
Show all 31Show fewer
  • has systemic lupus erythematosus
  • positive (or unknown) antiphospholipid antibodies
  • severe thrombocytopenia
  • has rheumatoid arthritis on immunosuppressive therapy
  • has migraine with aura
  • has unexplained vaginal bleeding
  • has diabetes
  • has strong family history of breast cancer (defined as one or more first degree relatives, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer), or current or history of breast cancer, or undiagnosed mass detected by breast exam
  • has current or history of cervical cancer
  • has severe cirrhosis (decompensated) or liver tumors
  • has known significant renal disease
  • used Depo-Provera Contraceptive Injection or Depo-subcutaneous Provera 104 (DMPA) products in the past 12 months
  • used any of the following medications within 1 month prior to enrollment:
  • any investigational drug
  • prohibited drugs per protocol
  • oral contraceptives, contraceptive ring or patch
  • levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
  • used a combined injectable contraceptive in the past 6 months
  • less than 3 months since the end of last pregnancy
  • currently lactating
  • is using or plans to use prohibited drugs per protocol in the next 18 months
  • has known sensitivity to MPA or inactive ingredients
  • has a plan to move to another location in the next 24 months
  • in the opinion of the investigator, potentially at elevated risk of HIV infection (eg, HIV -positive partner, IV drug use by self or by partner)
  • additional criteria apply, please contact the investigator for more information

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Teva Investigational Site 002

    Norfolk, Virginia, 23507

  • Teva Investigational Site 001

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Two-part, Phase 1, Exploratory and Dose-range Finding Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Women With Ovulatory Cycle

The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.

Being tested
TV-46046 - 400 mg/mL, TV-46046 - 200 mg/mL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TV-46046 - 400 mg/mLDrug

    A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL

  • TV-46046 - 200 mg/mLDrug

    A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL

Study groups in NCT02817464
Study groupRoleWhat they receive
TV-46046 - 1ExperimentalNot described
Receives: Drug: TV-46046 - 400 mg/mL
TV-46046 - 2ExperimentalNot described
Receives: Drug: TV-46046 - 200 mg/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1

    'Overall number of participants analyzed' = participants evaluable for this outcome measure.

    Measured: Day 1

  2. Part 1: Serum MPA Concentration at Day 7

    Measured: Day 7

  3. Part 1: Serum MPA Concentration at Day 28

    Measured: Day 28

  4. Part 1: Serum MPA Concentration at Day 91

    Measured: Day 91

  5. Part 1: Serum MPA Concentration at Day 182

    Measured: Day 182

  6. Part 1: Serum MPA Concentration at Day 210

    Measured: Day 210

  7. Part 1: Maximum Observed Serum Concentration (Cmax) of MPA

    Measured: Day 0 up to Week 52

  8. Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA

    Measured: Day 182

  9. Part 1: Time to Reach Cmax (Tmax) of MPA

    Measured: Day 0 up to Week 52

  10. Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA

    Measured: Day 0 up to Day 182

  11. Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA

    Measured: Day 0 up to Day 210

  12. Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA

    Measured: Day 0 up to Week 52

  13. Part 1: Apparent Terminal Half-life (t1/2) of MPA

    Measured: Day 0 up to Week 52

  14. Part 2: Time to Ovulation

    Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.

    Measured: Day 0 up to Week 78

Secondary outcomes (10)

  1. Part 1: Time to Ovulation

    Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate.

    Measured: Day 0 up to Week 78

  2. Part 2: Cmax of MPA

    Measured: Day 0 up to Week 52

  3. Part 2: Tmax of MPA

    Measured: Day 0 up to Week 52

  4. Part 2: Observed Serum Drug Concentration at Day 210 (C210) of MPA

    Measured: Day 0 up to Day 210

  5. Part 2: C182 of MPA

    Measured: Day 0 up to Day 182

  6. Part 2: AUC0-182 of MPA

    Measured: Day 0 up to Day 182

  7. Part 2: AUC0-210 of MPA

    Measured: Day 0 up to Day 210

  8. Part 2: AUC0-∞ of MPA

    Measured: Day 0 up to Week 52

  9. Part 2: Apparent Terminal Half Life (t1/2) of MPA

    Measured: Day 0 up to Week 52

  10. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Measured: Day 0 up to Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start26 Oct 2016
  3. Primary completion3 Dec 2018
  4. Study completion3 Dec 2018

Resources

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
Other
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817464
Sponsor's protocol ID
TV46046-WH-10075
Status last verified
Jun 2023
First submitted
27 Jun 2016
Last updated
12 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Halpern V, Wheeless A, Brache V, Lendvay A, Cochon L, Taylor D, Dorflinger LJ. A randomized crossover study to evaluate local tolerability following subcutaneous administration of a new depot medroxyprogesterone acetate contraceptive formulation. Contracept X. 2023 Sep 12;5:100100. doi: 10.1016/j.conx.2023.100100. eCollection 2023.

    PubMed 37823034

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TV-46046 - 400 mg/mL and TV-46046 - 200 mg/mL in people with Pregnancy and Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 2 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 6 inclusion and 31 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 12 Feb 2024. 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. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1 (time frame: Day 1). The study lists 14 primary outcomes in all. 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 NCT02817464, 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 12 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in