An interventional study of Drospinetta in Menstrual Bleeding, Heavy, sponsored by Azhar University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Azhar University · Not applicable, Interventional, and Treatment
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).
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.
182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.
This study's enrollment of 300 is above the median of 100 across 133 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →Azhar University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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About 100 women took Drospirenon (drospinetta) tab every day 24 and 4 placipo tablets for four days
Drug: Drospinetta
About 100 women took Desogestrel (Cirazette) tablet every day
Drug: Drospinetta
About 100 women took Levonorgestrel (Microlute) tablet every day
Drug: Drospinetta
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
Also known as: Cirazette, Micrlute
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
Time frame: 9 Months
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Azhar University