NCT05244811

Brief Summary

comparison between cocs and progesterone only containing pills in treatment of fuctional ovarian cyst

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

January 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

January 9, 2022

Last Update Submit

February 8, 2022

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

  • treatment of functional ovarian cysts

    rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills

    one year

Study Arms (3)

use of placebo in treatment of functional ovarian cyst

PLACEBO COMPARATOR

trial the effect of placebo in treatment of functional ovarian cyst

Drug: Combined Oral ContraceptiveDrug: Progestin

use of cocs in treatment of functional ovarian cyst

ACTIVE COMPARATOR

trial of the effectiveness of cocs in the treatment of functional ovarian cyst

Drug: Combined Oral ContraceptiveDrug: Progestin

use of progesterone in treatment of functional ovarian cyst

ACTIVE COMPARATOR

comparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs

Drug: Combined Oral ContraceptiveDrug: Progestin

Interventions

Combined Oral ContraceptiveDRUG

effect of cocs in treatment of ovarian cysts

Also known as: cyclo progynova
use of cocs in treatment of functional ovarian cystuse of placebo in treatment of functional ovarian cystuse of progesterone in treatment of functional ovarian cyst
ProgestinDRUG

effect of progestin in treatment of ovarian cystn

Also known as: primalot-nor
use of cocs in treatment of functional ovarian cystuse of placebo in treatment of functional ovarian cystuse of progesterone in treatment of functional ovarian cyst

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The current randomized, clinical trial was performed on females with:-
  • functional ovarian cysts (4 to 8 cm in diameter)
  • in reproductive age, within the age range of 18 to 48 years, referred to the Clinic of Gynecological Diseases in a private hospital as outpatient The cysts were identified by transvaginal ultrasonography

You may not qualify if:

  • were history of:-
  • endometrioma.
  • Other non-functional .ovarian neoplasm
  • OCPs consumption during the last three months The patients were randomly divided into three equals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Formuso C, Stracquadanio M, Ciotta L. Myo-inositol vs. D-chiro inositol in PCOS treatment. Minerva Ginecol. 2015 Aug;67(4):321-5. Epub 2015 Feb 11.

    PMID: 25670222BACKGROUND

  • Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, Hou LH, Hu ZX, Shao XG, Ge J, Zhang JF, Xue HY, Xu XF, Liang RN, Ma HX, Yang HW, Li WL, Huang DM, Sun Y, Hao CF, Du SM, Yang ZW, Wang X, Yan Y, Chen XH, Fu P, Ding CF, Gao YQ, Zhou ZM, Wang CC, Wu TX, Liu JP, Ng EHY, Legro RS, Zhang H; PCOSAct Study Group. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.

    PMID: 28655015BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Contraceptives, Oral, CombinedProgestins

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Drug CombinationsPharmaceutical PreparationsContraceptives, OralContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

salah mohamed rasheed, professor

CONTACT

01224653702salahrasheed67@yahoo.com

mamdouh elsemary aaied, dr

CONTACT

01062342515

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor in gynaecology and obstetric department in nasser general hospital

Study Record Dates

First Submitted

January 9, 2022

First Posted

February 17, 2022

Study Start

February 20, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 17, 2022

Record last verified: 2022-02