Abnormal Uterine Bleeding and Progestin-only Contraceptives
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|ClinicalTrials.gov Identifier: NCT03398811|
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : April 24, 2018
The use of progestin-only methods of contraception has been increased obviously and progressively over the world in the last few years. Progestin-only contraception is an option for women in whom an estrogen-containing contraceptive is either contraindicated or causes additional health concerns.
Progestogen-only pills are contraceptive pills that contain only synthetic progestogens (progestins) and do not contain estrogen . The progestin-only pill is recommended over regular birth control pills for women who are breastfeeding because the mini-pill does not affect milk production.
The most common progestin-only method used is the injectable depot medroxy-progesterone acetate which had been approved by Food and Drug Administration since 1992 . depot medroxy-progesterone acetate provides reliable, private, long-acting (three months) and reversible contraception. Users of depot medroxy-progesterone acetate don't need daily taking as well as it doesn't affect the intercourse by any mean.
The etonogestrel implant (Implanon) is a single-rod progestin contraceptive method placed subdermally in the inner aspect of upper non dependant arm for three years. Much evidence supports the safety, efficacy, reversibility and acceptability of this contraceptive method.
A common reason women choose to discontinue progestin-only contraception is dissatisfaction with its effects on uterine bleeding which occurs in a significant number of users. Information revealed from many clinical trials shows that abnormal uterine bleeding with progestin-only contraception ranging from 10 to 25 % at first year of use.
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Depot medroxy-progesterone acetate Drug: Etonogestrel Drug: Levonorgestrel Acetate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||February 2019|
Group I "the depot medroxy-progesterone acetate group"
where they will use Depot Medroxyprogesterone Acetate 150 mg injection every 3 month,
Drug: Depot medroxy-progesterone acetate
Injection every 3 months
Group II "Implanon group"
where they will have Implanon (etonogestrel implant) 68 mg implant
68 mg implant
group III (Microlut group)
where they are using Microlut pills (0.5 mg levonorgestrel) one pill every day for 35 days without pill-free interval.
Drug: Levonorgestrel Acetate
one pill every day for 35days without pill-free interval.
- Number of women developed vaginal bleeding [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398811
|Women Health Hospital - Assiut university||Recruiting|
|Assiut, Egypt, 71111|
|Contact: Mohammed K ALi, MD +201005537951 firstname.lastname@example.org|