Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT05742503

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Progesterone Contraceptive Methods	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 30, 2021

Actual Primary Completion Date :

Mar 30, 2022

Actual Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Ossman	Tanta	El-Gharbia	Egypt	31527

Sponsors and Collaborators

Tanta University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT05742503

Other Study ID Numbers:

36035/11/22

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Medroxyprogesterone Acetate

Medroxyprogesterone

Etonogestrel

Norgestrel

Study Results

No Results Posted as of Feb 24, 2023