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Status unknownNCT04783636Updated Mar 17, 2021

To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

A Phase 1 interventional study of leuprorelin acetate 3.75mg in Prostate Cancer, sponsored by Peptron, Inc.. Status unknown. Open to female participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Peptron, Inc. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years and older
Sex
Female
01

Study summary

The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers

Read the detailed description

The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 40 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Peptron, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening.
  • Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.

Exclusion criteria

Exclusion Criteria:

  • Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
  • Those whose plasma AST and ALT exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization
  • Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
  • Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Other
    A

    After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)

    Drug: leuprorelin acetate 3.75mg

  • Other
    B

    After a single administration of PT105 (leuprorelin acetate 3.75mg), a single administration of PT105R (leuprorelin acetate 3.75mg)

    Drug: leuprorelin acetate 3.75mg

Interventions

  • Drugleuprorelin acetate 3.75mg

    PT105, PT105R

    Also known as: PT105

06

What researchers measure

Primary outcomes

  1. AUC7-t of Leuprolide

    AUC7-t

    Time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr

  2. AUCt of Leuprolide

    AUCt

    Time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr

  3. AUCinf of Leuprolide

    AUCinf

    Time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr

  4. Cmax of Leuprolide

    Cmax

    Time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr

Secondary outcomes

  1. Tmax of Leuprolide

    Tmax

    Time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr

  2. t1/2 of Leuprolide

    t1/2

    Time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04783636
Lead sponsor
Peptron, Inc.
Responsible party
Sponsor
First posted
Mar 5, 2021
Start date
Mar 11, 2021 (estimated)
Primary completion
Jul 20, 2021 (estimated)
Completion
Jul 20, 2021 (estimated)
Last update
Mar 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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