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AzTrials

ContraceptionPhase 1NCT02456584

Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

A Phase 1 study testing DMPA 150, DMPA 300 and DMPA 104 in people with Contraception, run by FHI 360 at 2 sites in 2 countries.

Completed

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

Official record
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Trial summary

This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle. 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
Contraception
What is being tested?
DMPA 150, DMPA 300 and DMPA 104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesin 2 countries
Study dates
Sep 2015to 30 Aug 2018
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women may be included in the study if they meet all of the following criteria:
  • in good general health
  • age 18 to 40 years, inclusive
  • willing to provide informed consent and follow all study requirements
  • not pregnant
  • does not desire to become pregnant in the next 24 months
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  • regular menstrual cycle (24 to 35 days)
  • confirmed ovulation by serum P ≥ 4.7 ng/mL in two consecutive samples during the pre-treatment phase of the study
  • at low risk of pregnancy (e.g., sterilized, in exclusively same sex partnership, in monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD or condoms)
  • has a body mass index of 18.0 to 35.0
  • has hemoglobin ≥10.5 g/L

Who cannot join

  • Women will be excluded from participating in this study if they meet any of the following criteria:
  • medical contraindications to DMPA use
  • use of any of the following medications within 1 month prior to enrollment:
  • any investigational drug
  • prohibited drugs (per protocol)
  • oral contraceptives
Show all 15Show fewer
  • LNG IUS or implant
  • use of DMPA in the past 12 months
  • use of a combined injectable contraceptive in the past 6 months
  • recent pregnancy (within 3 months)
  • current lactation
  • ongoing or anticipated use of prohibited drugs (per protocol)
  • known sensitivity to MPA
  • plan to move to another location in the next 18 months
  • any condition (social or medical) which in the opinion of the site investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

Dominican Republic1 site

  • Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)

    Santo Domingo

Other trials in Dominican Republic

About this study

Official title: Pharmacodynamics (Suppression of Ovulation) and Pharmacokinetics Following a Single Subcutaneous Administration of Depo Provera® CI 150 mg/mL, Depo Provera® CI 300 mg/2 mL, or During Two Cycles of Depo-subQ Provera 104®

This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Read the detailed description

This is a randomized, multi-center, parallel-group Phase I study with a primary objective to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Secondary study objectives are:

  • To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of 150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered 3 months apart
  • To evaluate the relationship between serum MPA concentration and suppression of ovulation
  • To evaluate and compare the safety, tolerability and acceptability of a SC injection of DMPA of different frequencies, doses and volumes
Conditions
Contraception
Being tested
DMPA 150, DMPA 300, DMPA 104
Keywords
depot medroxyprogesterone acetate (DMPA), confidence interval (CI), Subcutaneous (sub-Q), Intrauterine device (IUD), Levonorgestrel (LNG), intrauterine system (IUS)

What participants receive

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

  • DMPA 150Drug

    Also called Depo-Provera® CI (150mg/mL, intramuscular)

    injectable contraceptive

  • DMPA 300Drug

    Also called Depo-Provera® CI (300mg/2mL, intramuscular)

    injectable contraceptive

  • DMPA 104Drug

    Also called depo-subQ provera 104® (104mg/0.65mL, sub-cutaneous)

    injectable contraceptive

Study groups in NCT02456584
Study groupRoleWhat they receive
DMPA 150Experimentalsingle subcutaneous injection of 150mg/mL of DMPA in the abdomen
Receives: Drug: DMPA 150
DMPA 300Experimentalsingle subcutaneous injection of 300mg/2mL of DMPA in the abdomen
Receives: Drug: DMPA 300
DMPA 104Active comparatortwo injections, given at three months intervals, of 104mg/0.65mL of DMPA in the abdomen
Receives: Drug: DMPA 104

What is being measured

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

  1. Measure of time to ovulation

    Measured: up to 18 months

Secondary outcomes (20)

  1. Cmax

    Up to ovulation or 18 months following injection, whichever comes first

    Measured: up to 18 months

  2. Aggregate of individual Cmax measurements and parameters

    Measured: up to 18 months

  3. Type and frequency of adverse events

    Measured: up to 18 months

  4. Blood pressure at follow up

    Measured: up to 18 months

  5. Pulse at follow up

    Measured: up to 18 months

  6. Weight at follow up

    Measured: up to 18 months

  7. Measure of delayed return to ovulation

    Measured: up to 18 months

  8. Serum concentrations of cortisol

    Measured: 7.5 months

  9. Number of participants with Injection site reactions

    Measured: up to 18 months

  10. Product acceptability

    Measured: up to 18 months

  11. Tmax

    Up to ovulation or 18 months following injection, whichever comes first

    Measured: up to 18 months

  12. Aggregate of individual Tmax measurements and parameters

    Measured: Up to 18 months

  13. MPA concentration at Day 91 (C91)

    Measured: 91 days after injection

  14. Aggregate of individual C91 measurements and parameters

    Measured: 18 months after injection

  15. MPA concentration at Day 182 (C182)

    Measured: 182 days after injection

  16. Aggregate of individual C182 measurements and parameters

    Measured: 18 months after injection

  17. MPA concentration at Day 210 (C210)

    Measured: 210 days after injection

  18. Aggregate of individual C210 measurements and parameters

    Measured: 18 months after injection

  19. Area under the curve (AUC 0-182)

    Measured: 182 days after injection

  20. Terminal elimination half-life (t1/2)

    Up to ovulation or 18 months following injection, whichever comes first

    Measured: up to 18 months

Timeline

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

  1. First posted28 May 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion30 Aug 2018
  4. Study completion30 Aug 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02456584
Sponsor's protocol ID
702179
Status last verified
Oct 2018
First submitted
11 May 2015
Last updated
18 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Halpern V, Brache V, Taylor D, Lendvay A, Cochon L, Jensen JT, Dorflinger LJ. Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera. Fertil Steril. 2021 Apr;115(4):1035-1043. doi: 10.1016/j.fertnstert.2020.11.002. Epub 2021 Jan 21.

    PubMed 33485608

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DMPA 150, DMPA 300 and DMPA 104 in people with Contraception, run by FHI 360 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 11 inclusion and 15 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 18 Oct 2018. 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, Dominican Republic. 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?

Measure of time to ovulation (time frame: up to 18 months). 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 NCT02456584, 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 18 Oct 2018.

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