ProgesteroneNCT05742503
Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level
An observational study of Progesterone and Contraceptive Methods, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Progesterone, Contraceptive Methods
- What is being tested?
- Depo-Provera, Implanon and Norgestrel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2021to 30 Mar 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Among patients attending Tanta University Hospitals
Who may be able to join
- 80 healthy fertile females
- 20-35 years
- With normal menstrual history
- Had at least one offspring after spontaneous pregnancy
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Progesterone, Contraceptive Methods
- Being tested
- Depo-Provera, Implanon, Norgestrel, Mirena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo-ProveraOther
Injectable progesterone
ImplanonOther
Etonogestrel implant
NorgestrelOther
Pill containing progesterone
MirenaOther
Levonorgestrel-releasing intra-uterine drug (IUD)
| Study group | Role | What they receive |
|---|---|---|
| Depo-Provera group | This group will receive150 mg of injectable progesterone every 90 days or 3 months Receives: Other: Depo-Provera | |
| Implanon group | This group will receive 68 mg of etonogestrel implant formerly known as Implanon. Receives: Other: Implanon | |
| Norgestrel group | This group will receive 0.075 mg of norgestrel (Ovrette®) once daily. Receives: Other: Norgestrel | |
| Mirena group | This group will receive IUD (Mirena) containing 52 mg of levonorgestrel. Receives: Other: Mirena |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start30 Mar 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProgesteroneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ossman, Tanta University
- Investigators
- Mona K Omar, MD, Principal investigator, Assistant Professor of Obstetrics and Gynecology Department, Faculty of Medicine,Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742503
- Sponsor's protocol ID
- 36035/11/22
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Progesterone Containing Contraceptive Methods on Safety and Endogenous Progesterone Level
- ClinicalTrials.gov ID
- NCT05742503
- Acronym / sponsor ID
- 36035/11/22
- Conditions
- Progesterone, Contraceptive Methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Depo-Provera group | – | Other: Depo-ProveraThis group will receive150 mg of injectable progesterone every 90 days or 3 months |
| Implanon group | – | Other: ImplanonThis group will receive 68 mg of etonogestrel implant formerly known as Implanon. |
| Norgestrel group | – | Other: NorgestrelThis group will receive 0.075 mg of norgestrel (Ovrette®) once daily. |
| Mirena group | – | Other: MirenaThis group will receive IUD (Mirena) containing 52 mg of levonorgestrel. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Among patients attending Tanta University Hospitals
Key inclusion criteria (4 listed)
- 80 healthy fertile females
- 20-35 years
- With normal menstrual history
- Had at least one offspring after spontaneous pregnancy
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depo-ProveraInjectable progesterone | Other | Depo-Provera group |
| ImplanonEtonogestrel implant | Other | Implanon group |
| NorgestrelPill containing progesterone | Other | Norgestrel group |
| MirenaLevonorgestrel-releasing intra-uterine drug (IUD) | Other | Mirena group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
Related trials for Progesterone
Not yet recruitingPhase 3
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Recruiting
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Active, not recruitingPhase 3
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Breast Cancer
Active, not recruitingPhase 1
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona K Omar, MD principal investigator
Assistant Professor of Obstetrics and Gynecology Department, Faculty of Medicine,Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progesterone and Contraceptive Methods, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level (time frame: Six mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.