Menstrual Bleeding, HeavyNCT06689150
Evaluation of the Contraceptive Efficacy
A study testing Drospinetta in people with Menstrual Bleeding, Heavy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Combined oral contraceptives are not the preparation of first choice in breastfeeding women as they may influence the quality and quantity of breast milk. In these cases, a progestogen-only pill is a suitable alternative, since progestogen-only pills contain no estrogen at all and a much lower dose of progestogen than… Read more about this study
- Who is it for?
- Ages 35 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Bleeding, Heavy
- What is being tested?
- Drospinetta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 10 Aug 2024
- Phase
- Interventional
- 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 35 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 45 years.
- Non obese women with BMI between 18.5 : 29.9 kg/m2.
- Healthy women with good physical and mental health.
- Sexually active.
- Women have normal cycles (regular interval, duration, and amount of bleeding.
- Women willing to accurately fill in the diary card with daily information on vaginal bleeding and pill intake
- Women willing to give written informed consent.
Who cannot join
- obese medical history
- Contraindications to the use of progesterone only pills with medical eligibility criteria mec category 3 or 4: (malabsorptive procedures, current or history of ischemic heart disease, history of cerebrovascular accident, systemic lupus erythematosus, breast cancer, cirrhosis, liver tumors or antimicrobial therapy).
- Women with allergy from study medications.
- Women refusing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Contraceptive Efficacy, and Safety of Different Types of Progestron Only Pills (Drosperinon 4 mg, Desogestrel 75 pg and Levonorgestrel 30 pg), A Comparative Randomized Controlled Trial
Combined oral contraceptives are not the preparation of first choice in breastfeeding women as they may influence the quality and quantity of breast milk. In these cases, a progestogen-only pill is a suitable alternative, since progestogen-only pills contain no estrogen at all and a much lower dose of progestogen than do combined oral contraceptives
Therefore, progestogen-only pills may also be more acceptable than combined oral contraceptives to women suffering from medical conditions that are associated with the use of combined oral contraceptives (e.g. nausea, headache and breast tension).
Read the detailed description
The most widely prescribed form of hormonal contraception is the combined oral contraceptive, which offers good contraceptive efficacy and a number of non-contraceptive benefits.
However, the combined pill has also been associated with some adverse effects, mainly related to the vascular system, i.e. a slightly higher risk of venous thromboembolic events .
Most studies have linked the risk of venous thromboembolic events dose dependently to the estrogen component. Estrogen-containing oral contraceptives may, therefore, be contraindicated in women with risk factors for venous thromboembolic events.
The current progestogen-only pills contain levonorgestrel, norethisterone, lynestrenol or ethynodiol diacetate have a multifaceted, mode of action .
Ovulation inhibition is achieved in about half of the cycles and contributes only partly to the effectiveness of the method, with effects on the cervical mucus and the endometrium, thus providing additional contraceptive reliability .
Drawbacks of the traditional progestogen-only pills in comparison to COCs are the high incidence of irregular bleeding, the higher rate of ectopic pregnancies and a slightly lower contraceptive efficacy. If a newly developed progestogen-only pill improves on one or more of these drawbacks, it may be a valuable addition to the traditional progestogen-only pills .
Levonorgestrel, also known as the morning-after pill, is a first-line oral emergency contraceptive pill with approval from the World Health Organization to prevent pregnancy. It is FDA-approved to be used within 72 hours of unprotected sexual intercourse or when a presumed contraceptive failure has occurred .
Desogestrel is a selective progestogen with a lower androgenic activity than the progestogens used in the traditional progestogen-only pills. Therefore, a dose that is high enough to obtain inhibition of ovulation is not likely to trigger androgen-related side-effects. Levonorgestrel is a second-generation synthetic progestogen that is the active component of the racemic mixture of norgestrel. It binds to progesterone and androgen receptors, where it can delay gonadotropin-releasing hormone from being released from the hypothalamus .
Drospirenone is a synthetic spironolactone analogue and progestin with progestational and anti-mineralocorticoid activity. Drospirenone binds to the progesterone receptor; the resulting complex becomes activated and binds to specific sites on DNA. This results in a suppression of LH activity and an inhibition of ovulation as well as an alteration in the cervical mucus and endometrium. This leads to an increased difficulty of sperm entry into the uterus and implantation. This drug is used in oral contraceptives.
- Conditions
- Menstrual Bleeding, Heavy
- Being tested
- Drospinetta
- Keywords
- Drospirenon, Desogestrel, Levonorgestrel
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrospinettaDrug
Also called Cirazette, Micrlute
To evaluate the three different types of POPs, the new POPs Drosperinon 4 mg, Desogestrel 75 pg, and Levonorgestrel 30 pg in healthy female subjects as regard to the contraceptive efficacy, bleeding pattern, acceptability and safety
| Study group | Role | What they receive |
|---|---|---|
| Group A: Drospirenon (drospinetta) | Active comparator | About 100 women took Drospirenon (drospinetta) tab every day 24 and 4 placipo tablets for four days Receives: Drug: Drospinetta |
| Group B: Desogestrel (Cirazette) | Active comparator | About 100 women took Desogestrel (Cirazette) tablet every day Receives: Drug: Drospinetta |
| Group C: Levonorgestrel (Microlute) | Active comparator | About 100 women took Levonorgestrel (Microlute) tablet every day Receives: Drug: Drospinetta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irregular Vaginal Bleeding
Efficacy of the different types of the progesterone only pills as : (Drosperinon tablets, Desogestrel tablets and Levonorgestrel tablets) which will be initiated on the first day of menstruation in controlling of irregular vaginal bleeding during menses
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start10 Aug 2023
- Primary completion1 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Bleeding, HeavyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Tullah Mohamed Alsyed, Al-Azhar University
- Investigators
- Ahmed Ali Mohamed Nasr, M.D, Study chair, Al-Azhar University, Assuit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689150
- Sponsor's protocol ID
- Hebatu Allah Mohamed
- Status last verified
- Aug 2023
- First submitted
- 25 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contraceptive Efficacy, and Safety of Different Types of Progestron Only Pills (Drosperinon 4 mg, Desogestrel 75 pg and Levonorgestrel 30 pg), A Comparative Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06689150
- Acronym / sponsor ID
- Hebatu Allah Mohamed
- Conditions
- Menstrual Bleeding, Heavy
- Keywords
- Drospirenon, Desogestrel, Levonorgestrel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 14 Nov 2024 (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.
Combined oral contraceptives are not the preparation of first choice in breastfeeding women as they may influence the quality and quantity of breast milk. In these cases, a progestogen-only pill is a suitable alternative, since progestogen-only pills contain no estrogen at all and a much lower dose of progestogen than do combined oral contraceptives
Therefore, progestogen-only pills may also be more acceptable than combined oral contraceptives to women suffering from medical conditions that are associated with the use of combined oral contraceptives (e.g. nausea, headache and breast tension).
Detailed description
The most widely prescribed form of hormonal contraception is the combined oral contraceptive, which offers good contraceptive efficacy and a number of non-contraceptive benefits.
However, the combined pill has also been associated with some adverse effects, mainly related to the vascular system, i.e. a slightly higher risk of venous thromboembolic events .
Most studies have linked the risk of venous thromboembolic events dose dependently to the estrogen component. Estrogen-containing oral contraceptives may, therefore, be contraindicated in women with risk factors for venous thromboembolic events.
The current progestogen-only pills contain levonorgestrel, norethisterone, lynestrenol or ethynodiol diacetate have a multifaceted, mode of action .
Ovulation inhibition is achieved in about half of the cycles and contributes only partly to the effectiveness of the method, with effects on the cervical mucus and the endometrium, thus providing additional contraceptive reliability .
Drawbacks of the traditional progestogen-only pills in comparison to COCs are the high incidence of irregular bleeding, the higher rate of ectopic pregnancies and a slightly lower contraceptive efficacy. If a newly developed progestogen-only pill improves on one or more of these drawbacks, it may be a valuable addition to the traditional progestogen-only pills .
Levonorgestrel, also known as the morning-after pill, is a first-line oral emergency contraceptive pill with approval from the World Health Organization to prevent pregnancy. It is FDA-approved to be used within 72 hours of unprotected sexual intercourse or when a presumed contraceptive failure has occurred .
Desogestrel is a selective progestogen with a lower androgenic activity than the progestogens used in the traditional progestogen-only pills. Therefore, a dose that is high enough to obtain inhibition of ovulation is not likely to trigger androgen-related side-effects. Levonorgestrel is a second-generation synthetic progestogen that is the active component of the racemic mixture of norgestrel. It binds to progesterone and androgen receptors, where it can delay gonadotropin-releasing hormone from being released from the hypothalamus .
Drospirenone is a synthetic spironolactone analogue and progestin with progestational and anti-mineralocorticoid activity. Drospirenone binds to the progesterone receptor; the resulting complex becomes activated and binds to specific sites on DNA. This results in a suppression of LH activity and an inhibition of ovulation as well as an alteration in the cervical mucus and endometrium. This leads to an increased difficulty of sperm entry into the uterus and implantation. This drug is used in oral contraceptives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Drospirenon (drospinetta) | Active comparator | Drug: DrospinettaAbout 100 women took Drospirenon (drospinetta) tab every day 24 and 4 placipo tablets for four days |
| Group B: Desogestrel (Cirazette) | Active comparator | Drug: DrospinettaAbout 100 women took Desogestrel (Cirazette) tablet every day |
| Group C: Levonorgestrel (Microlute) | Active comparator | Drug: DrospinettaAbout 100 women took Levonorgestrel (Microlute) tablet every day |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18 - 45 years.
- Non obese women with BMI between 18.5 : 29.9 kg/m2.
- Healthy women with good physical and mental health.
- Sexually active.
- Women have normal cycles (regular interval, duration, and amount of bleeding.
Key exclusion criteria (4 listed)
- obese medical history
- Contraindications to the use of progesterone only pills with medical eligibility criteria mec category 3 or 4: (malabsorptive procedures, current or history of ischemic heart disease, history of cerebrovascular accident, systemic lupus erythematosus, breast cancer, cirrhosis, liver tumors or antimicrobial therapy).
- Women with allergy from study medications.
- Women refusing to participate in the study.
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 |
|---|---|---|
| DrospinettaAlso: Cirazette, MicrluteTo evaluate the three different types of POPs, the new POPs Drosperinon 4 mg, Desogestrel 75 pg, and Levonorgestrel 30 pg in healthy female subjects as regard to the contraceptive efficacy, bleeding pattern, acceptability and safety | Drug | Group A: Drospirenon (drospinetta), Group B: Desogestrel (Cirazette), Group C: Levonorgestrel (Microlute) |
Primary outcome
Irregular Vaginal Bleeding
Time frame: 9 Months
Efficacy of the different types of the progesterone only pills as : (Drosperinon tablets, Desogestrel tablets and Levonorgestrel tablets) which will be initiated on the first day of menstruation in controlling of irregular vaginal bleeding during menses
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 14 Nov 2024.
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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.
Ahmed Ali Mohamed Nasr, M.D study chair
Al-Azhar University, Assuit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drospinetta in people with Menstrual Bleeding, Heavy, run by Al-Azhar 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 7 inclusion and 4 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 14 Nov 2024. 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?
Irregular Vaginal Bleeding (time frame: 9 Months). 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 14 Nov 2024.