ContraceptionNCT03398811
Abnormal Uterine Bleeding and Progestin-only Contraceptives
An observational study of Contraception, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Depot medroxy-progesterone acetate, Etonogestrel and Desogestrel 75 µg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 390 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Nov 2020
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: women who requested DMPA, etonogestrel subdermal implant or POPs for pregnancy prevention.
Who may be able to join
- Women aged between 18-40 years.
- Women with more than 12 month postpartum.
- Women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle length variation of no more than 5 days, bleeding days from 2-7 days and number of sanitary pads not more than 3 pads without blood clots or flooding of blood).
- Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy prevention for at least 1 year.
Who cannot join
- Women on any anticoagulant therapy.
- Women who had a history of uterine, cervical or ovarian pathology.
- Women who had uterine bleeding disturbance (including amenorrhea) before recruitment.
- Women received DMPA injection within the previous 9 months except they had three spontaneous regular menstrual cycles.
- Severely anemic women (hemoglobin < 8gm/dl).
- Women with any contraindications for POCs following the WHO eligibility (Altshuler AL et al., 2015).
- Women refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users
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.
Read more
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.
- Conditions
- Contraception
- Being tested
- Depot medroxy-progesterone acetate, Etonogestrel, Desogestrel 75 µg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot medroxy-progesterone acetateDrug
Injection every 3 months
EtonogestrelDrug
68 mg implant
Desogestrel 75 µgDrug
one pill every day for 28 days without pill-free interval.
| Study group | Role | What they receive |
|---|---|---|
| Group I "the depot medroxy-progesterone acetate group" | where they will use Depot Medroxyprogesterone Acetate 150 mg injection every 3 month, Receives: Drug: Depot medroxy-progesterone acetate | |
| Group II "Implanon group" | where they will have Implanon (etonogestrel implant) 68 mg implant Receives: Drug: Etonogestrel | |
| group III (cerazette group) | where they are using Cerazette pills (desogestrel 75 µg l) one pill every day for 28 days without pill-free interval. Receives: Drug: Desogestrel 75 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women developed vaginal bleeding
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398811
- Sponsor's protocol ID
- POCU
- Status last verified
- Dec 2020
- First submitted
- 7 Jan 2018
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users
- ClinicalTrials.gov ID
- NCT03398811
- Acronym / sponsor ID
- POCU
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 12 Jan 2018 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I "the depot medroxy-progesterone acetate group" | – | Drug: Depot medroxy-progesterone acetatewhere they will use Depot Medroxyprogesterone Acetate 150 mg injection every 3 month, |
| Group II "Implanon group" | – | Drug: Etonogestrelwhere they will have Implanon (etonogestrel implant) 68 mg implant |
| group III (cerazette group) | – | Drug: Desogestrel 75 µgwhere they are using Cerazette pills (desogestrel 75 µg l) one pill every day for 28 days without pill-free interval. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women who requested DMPA, etonogestrel subdermal implant or POPs for pregnancy prevention.
Key inclusion criteria (4 listed)
- Women aged between 18-40 years.
- Women with more than 12 month postpartum.
- Women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle length variation of no more than 5 days, bleeding days from 2-7 days and number of sanitary pads not more than 3 pads without blood clots or flooding of blood).
- Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy prevention for at least 1 year.
Key exclusion criteria (7 listed)
- Women on any anticoagulant therapy.
- Women who had a history of uterine, cervical or ovarian pathology.
- Women who had uterine bleeding disturbance (including amenorrhea) before recruitment.
- Women received DMPA injection within the previous 9 months except they had three spontaneous regular menstrual cycles.
- Severely anemic women (hemoglobin < 8gm/dl).
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 |
|---|---|---|
| Depot medroxy-progesterone acetateInjection every 3 months | Drug | Group I "the depot medroxy-progesterone acetate group" |
| Etonogestrel68 mg implant | Drug | Group II "Implanon group" |
| Desogestrel 75 µgone pill every day for 28 days without pill-free interval. | Drug | group III (cerazette group) |
Primary outcome
Number of women developed vaginal bleeding
Time frame: 12 month
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 17 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Contraception, run by Assiut 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 7 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 17 Dec 2020. 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?
Number of women developed vaginal bleeding (time frame: 12 month). 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 17 Dec 2020.