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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
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Etonogestrel
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.



Primary Outcome Measures :
  1. Number of women developed vaginal bleeding [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women who will use the method only for pregnancy prevention for at least 6-12 month.
  2. Have not any known or incidental gynecological ultrasound abnormalities.
  3. Have not any medical or gynecologic problem.
  4. Living in a nearby area to make follow-up reasonably possible.

Exclusion Criteria:

  • Refuse the participation in the study.

Information from the National Library of Medicine

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


Locations
Egypt
Women Health Hospital - Assiut university Recruiting
Assiut, Egypt, 71111
Contact: Mohammed K ALi, MD    +201005537951    m_khairy2001@yahoo.com   
Sponsors and Collaborators
Assiut University

Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03398811     History of Changes
Other Study ID Numbers: POCU
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Contraceptive Agents
Levonorgestrel
Etonogestrel
Medroxyprogesterone
Medroxyprogesterone Acetate
Progesterone
Progestins
Reproductive Control Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents