Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level

Progesterone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742503
• Other study ID #: 36035/11/22
• Status: Completed
• Start date: March 30, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: February 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Progesterone

Intervention

Other:
• Depo-Provera
Injectable progesterone
• Implanon
Etonogestrel implant
• Norgestrel
Pill containing progesterone
• Mirena
Levonorgestrel-releasing intra-uterine drug (IUD)

Locations

Country	Name	City	State
Egypt	Ahmed Ossman	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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