Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level

Effects of Different Progesterone Containing Contraceptive Methods on Safety and Endogenous Progesterone Level

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

Study Overview

• Status: Completed
• Conditions: Progesterone; Contraceptive Methods
• Intervention / Treatment: Other: Depo-Provera; Other: Implanon; Other: Norgestrel; Other: Mirena

Detailed Description

Progestogen-only' contraceptives are presented as injections, implants, oral formulations, hormone-releasing intrauterine methods and emergency contraceptives. These substances could be used by females who are breastfeeding or have other contraindications to estrogen treatment, including those who are immediately postpartum, have thalassemia, sickle-cell disease, gallbladder disease, or currently experiencing thrombo-embolic disorders, valvular heart disease, ischemic heart disease.

Intrauterine, injectable methods and contraceptive implants named as long-acting reversible contraceptives (LARC) are the more efficient reversible contraceptive approaches are highly effective, longer-acting contraceptive methods levels.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Ahmed Ossman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Among patients attending Tanta University Hospitals

Description

Inclusion Criteria:

• 80 healthy fertile females
• 20-35 years
• With normal menstrual history
• Had at least one offspring after spontaneous pregnancy

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Depo-Provera group; This group will receive150 mg of injectable progesterone every 90 days or 3 months	Other: Depo-Provera; Injectable progesterone
Implanon group; This group will receive 68 mg of etonogestrel implant formerly known as Implanon.	Other: Implanon; Etonogestrel implant
Norgestrel group; This group will receive 0.075 mg of norgestrel (Ovrette®) once daily.	Other: Norgestrel; Pill containing progesterone
Mirena group; This group will receive IUD (Mirena) containing 52 mg of levonorgestrel.	Other: Mirena; Levonorgestrel-releasing intra-uterine drug (IUD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mona K Omar, MD, Assistant Professor of Obstetrics and Gynecology Department, Faculty of Medicine,Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone; Etonogestrel; Norgestrel
• Other Study ID Numbers: 36035/11/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: One year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No