Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level

NCT ID: NCT05742503

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2022-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Progesterone Contraceptive Methods

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Depo-Provera group

This group will receive150 mg of injectable progesterone every 90 days or 3 months

Depo-Provera

Intervention Type OTHER

Injectable progesterone

Implanon group

This group will receive 68 mg of etonogestrel implant formerly known as Implanon.

Implanon

Intervention Type OTHER

Etonogestrel implant

Norgestrel group

This group will receive 0.075 mg of norgestrel (Ovrette®) once daily.

Norgestrel

Intervention Type OTHER

Pill containing progesterone

Mirena group

This group will receive IUD (Mirena) containing 52 mg of levonorgestrel.

Mirena

Intervention Type OTHER

Levonorgestrel-releasing intra-uterine drug (IUD)

Interventions

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Depo-Provera

Injectable progesterone

Intervention Type OTHER

Implanon

Etonogestrel implant

Intervention Type OTHER

Norgestrel

Pill containing progesterone

Intervention Type OTHER

Mirena

Levonorgestrel-releasing intra-uterine drug (IUD)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ossman

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona K Omar, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Ahmed Ossman

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36035/11/22

Identifier Type: -

Identifier Source: org_study_id

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