Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level

February 14, 2023 updated by: Ahmed Ossman, Tanta University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Six mounths
The effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level will be recorded
Six mounths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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