NCT03898401

Brief Summary

30 postmenopausal females with senile vaginitis will be enrolled with score of \<15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 19, 2019

Last Update Submit

March 29, 2019

Conditions

Senile Vaginitis

Outcome Measures

Primary Outcomes (1)

  • Evaluation of vaginal mucosa using vaginal health index score

    Elasticity,fluid volume,integrity,pH,moisture

    6 months

Secondary Outcomes (1)

  • Female Sexual Distress (FSD) scale

    6 months

Study Arms (30)

1 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

2 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

3 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

4 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

5 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

6 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

7 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

8 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

9 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

10 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

11 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

12 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

13 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

14 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

15 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

16 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

17 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

18 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

19 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

20 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

21 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

22 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

23 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

24 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

25 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

26 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

27PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

28 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

29 PRP

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

30 PRp

EXPERIMENTAL

Inclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index \<15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy.

Combination Product: Platelet rich plasma

Interventions

Platelet rich plasmaCOMBINATION_PRODUCT

After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.

1 PRP10 PRP11 PRP12 PRP13 PRP14 PRP15 PRP16 PRP17 PRP18 PRP19 PRP2 PRP20 PRP21 PRP22 PRP23 PRP24 PRP25 PRP26 PRP27PRP28 PRP29 PRP3 PRP30 PRp4 PRP5 PRP6 PRP7 PRP8 PRP9 PRP

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal for at least 3 years.
  • Vaginal health index \<15.
  • Any parity.

You may not qualify if:

  • Women with vaginal infection.
  • Women taking estrogen therapy for senile vaginitis.
  • Any patient with medical disorder especially diabetes mellitus.
  • Previous vaginal surgery as fistula repair or classical repair.
  • Vaginal prolapse
  • Any patient taking chemo or radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain shams University

Cairo, Elabbasia, 13211, Egypt

RECRUITING

Ain shams university hospital

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Hamid ASA, AbdAllah AM, Fathi HM, Eldin AMB, Abd El Hadi RMM. Value of injection of plasma-rich platelets in the vaginal mucosa in cases with vulvovaginal atrophy: a prospective double-blinded randomized controlled study. BMC Womens Health. 2025 Nov 25;25(1):576. doi: 10.1186/s12905-025-04076-5.

    PMID: 41291715DERIVED

MeSH Terms

Conditions

Atrophic Vaginitis

Condition Hierarchy (Ancestors)

VaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Rasha Medhat, Professor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasha Medhat, Professor

CONTACT

01224448449rashamedhat30@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 19, 2019

First Posted

April 2, 2019

Study Start

March 18, 2019

Primary Completion

September 30, 2019

Study Completion

October 30, 2019

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)