Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level

Completed

• Conditions: Progesterone; Contraceptive Methods
• Interventions: Other: Mirena; Other: Norgestrel; Other: Implanon; Other: Depo-Provera

• Registration Number: NCT05742503
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Study Start: 2021-03-30
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Study First Submitted: 2022-12-15
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mirena group	Mirena	This group will receive IUD (Mirena) containing 52 mg of levonorgestrel.
Norgestrel group	Norgestrel	This group will receive 0.075 mg of norgestrel (Ovrette®) once daily.
Implanon group	Implanon	This group will receive 68 mg of etonogestrel implant formerly known as Implanon.
Depo-Provera group	Depo-Provera	This group will receive150 mg of injectable progesterone every 90 days or 3 months

Primary Outcome Measures

Name	Time	Method
Assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level	Six mounths	The effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level will be recorded

Trial Locations

Locations (1)

Ahmed Ossman; 🇪🇬 Tanta, El-Gharbia, Egypt