Evidence map›Paper›PMID 33485608›Full record

Trial reportFertility and sterility2021

Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera.

Vera Halpern, Vivian Brache, Douglas Taylor, Anja Lendvay, Leila Cochón, Jeffrey T Jensen, Laneta J Dorflinger

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Fertility and sterility, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02456584 (Pharmacodynamics), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02456584 phase1completednot on this map

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®

TypeinterventionalSponsorFHI 360Ran2015 to 2018Enrolled42ConditionsContraceptionArmsDMPA 150, DMPA 300, DMPA 104
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Medroxyprogesterone acetate and meningioma: a global issue.Frontiers in global women's health · 2025
    Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Vera HalpernFHI 360, Durham, North Carolina. Electronic address: vhalpern@fhi360.org.
Vivian BracheProfamilia, Biomedical Research Department, Santo Domingo, Dominican Republic.
Douglas TaylorFHI 360, Durham, North Carolina.
Anja LendvayFHI 360, Durham, North Carolina.
Leila CochónProfamilia, Biomedical Research Department, Santo Domingo, Dominican Republic.
Jeffrey T JensenDepartment of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.
Laneta J DorflingerFHI 360, Durham, North Carolina.
Family Health International 360 · USProfamilia · DOOregon Health & Science University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after a single subcutaneous injection in the abdomen of 150 or 300 mg Depo-Provera and compare results to two injections of Depo-SubQ Provera 104 given 3 months apart.

designPartially randomized, multicenter, parallel-group study.

settingResearch unit. PATIENT(S): Forty-two women of reproductive age with confirmed ovulatory cycle and body mass index of 18-35 kg/m INTERVENTION(S): Women received a single subcutaneous injection of 150 mg (n = 24) or 300 mg (n = 9) of Depo-Provera or two injections of Depo-SubQ Provera 104 (n = 9). MAIN OUTCOME MEASURE(S): Suppression of ovulation as measured by progesterone, serum medroxyprogesterone acetate concentrations, and estimated pharmacokinetics parameters. RESULT(S): No ovulations were observed during 7 months after a single injection of 150 or 300 mg Depo-Provera. The 150 mg group had a similar C CONCLUSION(S): Our pharmacodynamics and pharmacokinetics data provide proof of concept that Depo-Provera (150 mg) may be an effective contraceptive method when injected subcutaneously every 6 months, with up to a 4-week grace period for reinjections. CLINICAL TRIAL REGISTRATION NUMBER: NCT02456584.

Indexed as

AdultContraceptive Agents, FemaleFemaleHumansInjections, SubcutaneousMedroxyprogesterone AcetateOvulationContraceptive Agents, FemaleMedroxyprogesterone AcetatecontraceptionDepot medroxyprogesterone acetatepharmacokineticssubcutaneoussuppression of ovulation

Identifiers

PMID33485608
PMCPMC8051852
OpenAlexW3125201249

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.