Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level

NCT05742503 | Completed

• 1 other identifier: 36035/11/22
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level

Conditions

Progesterone; Contraceptive Methods

Outcome Measures

Primary Outcomes (1)

• Assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level

  The effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level will be recorded

  Six mounths

Study Arms (4)

Depo-Provera group

This group will receive150 mg of injectable progesterone every 90 days or 3 months

Other: Depo-Provera

Implanon group

This group will receive 68 mg of etonogestrel implant formerly known as Implanon.

Other: Implanon

Norgestrel group

This group will receive 0.075 mg of norgestrel (Ovrette®) once daily.

Other: Norgestrel

Mirena group

This group will receive IUD (Mirena) containing 52 mg of levonorgestrel.

Other: Mirena

Interventions

Depo-Provera OTHER

Injectable progesterone

Depo-Provera group

Implanon OTHER

Etonogestrel implant

Implanon group

Norgestrel OTHER

Pill containing progesterone

Norgestrel group

Mirena OTHER

Levonorgestrel-releasing intra-uterine drug (IUD)

Mirena group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Among patients attending Tanta University Hospitals

You may qualify if:

• healthy fertile females
• years
• With normal menstrual history
• Had at least one offspring after spontaneous pregnancy

You may not qualify if:

• Any disease affects uterus (uterine tumors fibroids, endometriosis, prolapse, or tuberculosis).
• Ovarian tumors
• submucous myoma
• irregular menstrual cycle
• past or family history of breast disease
• Diabetic patients,
• medication affecting reproductive or metabolic functions.
• endometrial thickness \<7 mm on the secretory transformation day
• history of spontaneous abortions
• history of embryo transfer failure on over three occasions
• Patients had cortisol medications
• patients who received radiological treatment

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ahmed Ossman

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate; etonogestrel; Norgestrel; Levonorgestrel

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnenes; Norpregnanes; Norsteroids

Study Officials

• Mona K Omar, MD

  Assistant Professor of Obstetrics and Gynecology Department, Faculty of Medicine,Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology Department,Faculty of Medicine,Tanta University

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 24, 2023
• Study Start: March 30, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year

Locations

EG (1)