Menstrual CupNCT06718790
The Effect of Menstrual Cup Use on Menstrual Life and Sleep Quality
A study testing Using menstrual cup and Using menstrual pads in people with Menstrual Cup, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Women's reproductive age is an important process that begins with menarche and ends with menopause. During this period, women need to use safe, effective and affordable products during their menstrual periods. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Menstrual Cup
- What is being tested?
- Using menstrual cup and Using menstrual pads
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 24 Apr 2025
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-45,
- Having a regular menstrual cycle between 21-35 days,
- Not having a sexually transmitted disease that has been diagnosed and treated,
- Not having a silicone allergy,
- Not using an intrauterine device,
- Not having a vaginal anatomical defect,
- Not having given birth vaginally (since a standard size menstrual cup will be used)
Who cannot join
- Those planning to get pregnant,
- Those with a history of sexually transmitted diseases in the last 6 months,
- Those with dysmenorrhea problems will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Women's reproductive age is an important process that begins with menarche and ends with menopause. During this period, women need to use safe, effective and affordable products during their menstrual periods. While disposable pads and tampons are the most preferred products today, environmentally friendly and economical options also include menstrual cups, menstrual underwear and reusable pads. Menstrual cups are made of non-toxic silicone or latex, are inserted into the vagina and collect menstrual blood. Studies show that menstrual cups do not have a negative effect on the vaginal flora and most users are satisfied with the product. The environmental impact of menstrual hygiene products should also be taken into account. While disposable pads and tampons harm the environment due to their plastic content, menstrual cups are more sustainable and economical in the long term. In addition, women may experience problems with sleep quality, mood and physical comfort due to the effects of hormones during the menstrual period. However, there is no randomized controlled study yet examining the effects of menstrual cup use on sleep quality and quality of life. The aim of this study was to evaluate the effects of menstrual cup use on menstrual life and sleep quality.
Read the detailed description
The reproductive age, which constitutes an important part of women's lives, is a process that begins with menarche and continues until menopause. Menstruation is the vaginal discharge of menstrual blood and endometrial tissue during the reproductive age. For women of reproductive age, the menstrual cycle lasts 2-7 days once every 21-35 days on average. Menstrual cycles are generally anovulatory and irregular for at least 2 years following menarche. However, women need to use safe, effective and affordable menstrual products during their menstrual periods. Today, there are many menstrual hygiene products offered to women. Disposable menstrual pads and tampons are the most frequently preferred products. However, new generation products include menstrual cups, menstrual panties, reusable/washable pads and sea sponges. Each of these products has advantages and disadvantages. Menstrual cups, menstrual panties, reusable/washable pads are environmentally friendly and economical products as they can be used for a long time. In addition, pads and tampons are single-use products. While products such as tampons, menstrual cups and sea sponges are placed inside the vagina, pads and menstrual panties are used outside the vagina. However, improper use of menstrual hygiene products can result in health problems such as toxic shock syndrome and risk of infection. Therefore, it is important to have correct information about how to use them.
A woman uses approximately 6000 menstrual pads during her reproductive years. Non-biodegradable waste management consisting of traditional single-use menstrual pads is an important issue for environmental health. In low-income countries, incorrect practices in the disposal of menstrual products cause blockages in sewage pipes and negatively affect sanitation systems. Therefore, menstruation management should also be considered as a public health issue.
Among single-use menstrual hygiene products, single-use menstrual pads in particular affect the environment with their plastic content. In addition, harmful substances such as cyanide, dioxin and bleaches that can negatively affect not only environmental health but also genital health are encountered. In this respect, one of the sustainable menstrual hygiene products that can have less impact on both the environment and genital health is the menstrual cup. A menstrual cup is a reusable menstrual hygiene product that is placed inside the vagina and collects the blood flowing during menstruation. Menstrual cups are usually made of antitoxic silicone or latex. They are also designed in the form of a flexible bell or cup to facilitate women's self-use. There are thoughts that using a menstrual cup may cause toxicity and infection. However, a systematic review and meta-analysis study did not find a negative effect of menstrual cup use on the vaginal flora. However, 5 of the participants reported vaginal pain or sores, 6 allergies or redness, 9 urinary tract complaints and 5 toxic shock syndrome. In the same study, it was reported that 73% of the women using a menstrual cup wanted to continue using the product after the study ended. Sica et al. A study was conducted to evaluate the safety of menstrual cups made of medical silicone. In the study, menstrual cups were evaluated in terms of biocompatibility and chemical safety, physical effect on the vaginal mucosa, effect on the vaginal microbiota and the risk of Staphylococcus aureus growth and toxic shock syndrome. At the end of the study, it was reported that the menstrual cup did not pose a safety problem and was well tolerated. In a study conducted in Kenya, no difference was found in Staphylococcus aureus prevalence in menstrual cup users. One of the factors affecting the use of menstrual hygiene products is economic reasons. Although menstrual cups are expensive when first purchased compared to disposable products, they provide advantages in terms of both cost and solid waste within approximately 6 months of use. During the menstrual period, women may experience problems with mood, body temperature, respiration, autonomic nervous system and sleep regulation due to the effects of reproductive hormones. Sleep problems usually increase in the few days before menstruation and in the first days of menstruation. The cause of sleep problems during the menstrual period may be menstrual period symptoms, menstrual cycle characteristics, or individual-specific reasons. There are limited studies evaluating the menstrual life and sleep quality of women during the menstrual period. Studies conducted focus more on the effects of menstrual symptoms on quality of life. No randomized controlled study has been found examining the effects of menstrual cup use on quality of life and sleep. This study aimed to examine the effects of menstrual cup use on menstrual life and quality of sleep.
- Conditions
- Menstrual Cup
- Being tested
- Using menstrual cup, Using menstrual pads
- Keywords
- Menstrual Cup, Sleep Quality, Menstruation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using menstrual cupOther
In the prospective, randomized controlled study, two groups (Case = Menstrual cup, Control = Menstrual pad) will be randomly formed from individuals who volunteer to participate in the study and meet the inclusion criteria. All participants will be asked to answer the questions in the first interview questionnaire.
Women who will use menstrual cups will be trained on the use of the product and a menstrual cup will be provided for them to use. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual cup use by sharing an online form.
Using menstrual padsOther
In the prospective, randomized controlled study, two groups (Case = Menstrual cup, Control = Menstrual pad) will be randomly formed from individuals who volunteer to participate in the study and meet the inclusion criteria. All participants will be asked to answer the questions in the first interview questionnaire. For women in the group who will use menstrual pads, the average number of pads they have used in their previous menstrual cycles will be asked and an appropriate number of menstrual pads will be provided. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd, and 6th menstrual cycles and asked to answer questions about their menstrual pad use by sharing an online form.
| Study group | Role | What they receive |
|---|---|---|
| Menstrual cup users | Active comparator | Women who will use menstrual cups will be trained on the use of the product and a menstrual cup will be provided for them to use. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual cup use by sharing an online form. Receives: Other: Using menstrual cup |
| Menstrual pad users | Active comparator | For women in the group who will use menstrual pads, the average number of pads they have used in their previous menstrual cycles will be asked and an appropriate number of menstrual pads will be provided. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual pad use by sharing an online form. Receives: Other: Using menstrual pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
It was developed to evaluate sleep quality.
Measured: The scale will be used at the end of Cycle 1, 2, 3 and 6 (each cycle is 28 days)
Secondary outcomes (1)
Menstruation Impact Scale
The scale is used to measure the effects of menstruation. Menstruation Impact Scale is a 14-item scale consisting of physical and psychosocial impact subscales. The scale is a 5 point Likert type scale evaluated between "5" Strongly Agree and "1" Strongly Disagree. The minimum and maximum scores to be obtained from the overall scale are 14 and 70 respectively. As the score increases, the participant's degree of being affected by menstruation increases as well.
Measured: The scale will be used at the end of Cycle 1, 2, 3 and 6 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Aug 2024
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CupStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, there are two groups: menstrual cup users and menstrual pad users
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Elkan Kiyat, Trakya University
- Investigators
- Zeliha Elkan Kiyat, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718790
- Sponsor's protocol ID
- TU-HEM-ZEK-01
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data will be shared upon contact with researchers conducting meta-analysis or systematic reviews.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menstrual Cup Use on Menstrual Life and Sleep Quality
- ClinicalTrials.gov ID
- NCT06718790
- Acronym / sponsor ID
- TU-HEM-ZEK-01
- Conditions
- Menstrual Cup
- Keywords
- Menstrual Cup, Sleep Quality, Menstruation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 5 Dec 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.
Women's reproductive age is an important process that begins with menarche and ends with menopause. During this period, women need to use safe, effective and affordable products during their menstrual periods. While disposable pads and tampons are the most preferred products today, environmentally friendly and economical options also include menstrual cups, menstrual underwear and reusable pads. Menstrual cups are made of non-toxic silicone or latex, are inserted into the vagina and collect menstrual blood. Studies show that menstrual cups do not have a negative effect on the vaginal flora and most users are satisfied with the product. The environmental impact of menstrual hygiene products should also be taken into account. While disposable pads and tampons harm the environment due to their plastic content, menstrual cups are more sustainable and economical in the long term. In addition, women may experience problems with sleep quality, mood and physical comfort due to the effects of hormones during the menstrual period. However, there is no randomized controlled study yet examining the effects of menstrual cup use on sleep quality and quality of life. The aim of this study was to evaluate the effects of menstrual cup use on menstrual life and sleep quality.
Detailed description
The reproductive age, which constitutes an important part of women's lives, is a process that begins with menarche and continues until menopause. Menstruation is the vaginal discharge of menstrual blood and endometrial tissue during the reproductive age. For women of reproductive age, the menstrual cycle lasts 2-7 days once every 21-35 days on average. Menstrual cycles are generally anovulatory and irregular for at least 2 years following menarche. However, women need to use safe, effective and affordable menstrual products during their menstrual periods. Today, there are many menstrual hygiene products offered to women. Disposable menstrual pads and tampons are the most frequently preferred products. However, new generation products include menstrual cups, menstrual panties, reusable/washable pads and sea sponges. Each of these products has advantages and disadvantages. Menstrual cups, menstrual panties, reusable/washable pads are environmentally friendly and economical products as they can be used for a long time. In addition, pads and tampons are single-use products. While products such as tampons, menstrual cups and sea sponges are placed inside the vagina, pads and menstrual panties are used outside the vagina. However, improper use of menstrual hygiene products can result in health problems such as toxic shock syndrome and risk of infection. Therefore, it is important to have correct information about how to use them.
A woman uses approximately 6000 menstrual pads during her reproductive years. Non-biodegradable waste management consisting of traditional single-use menstrual pads is an important issue for environmental health. In low-income countries, incorrect practices in the disposal of menstrual products cause blockages in sewage pipes and negatively affect sanitation systems. Therefore, menstruation management should also be considered as a public health issue.
Among single-use menstrual hygiene products, single-use menstrual pads in particular affect the environment with their plastic content. In addition, harmful substances such as cyanide, dioxin and bleaches that can negatively affect not only environmental health but also genital health are encountered. In this respect, one of the sustainable menstrual hygiene products that can have less impact on both the environment and genital health is the menstrual cup. A menstrual cup is a reusable menstrual hygiene product that is placed inside the vagina and collects the blood flowing during menstruation. Menstrual cups are usually made of antitoxic silicone or latex. They are also designed in the form of a flexible bell or cup to facilitate women's self-use. There are thoughts that using a menstrual cup may cause toxicity and infection. However, a systematic review and meta-analysis study did not find a negative effect of menstrual cup use on the vaginal flora. However, 5 of the participants reported vaginal pain or sores, 6 allergies or redness, 9 urinary tract complaints and 5 toxic shock syndrome. In the same study, it was reported that 73% of the women using a menstrual cup wanted to continue using the product after the study ended. Sica et al. A study was conducted to evaluate the safety of menstrual cups made of medical silicone. In the study, menstrual cups were evaluated in terms of biocompatibility and chemical safety, physical effect on the vaginal mucosa, effect on the vaginal microbiota and the risk of Staphylococcus aureus growth and toxic shock syndrome. At the end of the study, it was reported that the menstrual cup did not pose a safety problem and was well tolerated. In a study conducted in Kenya, no difference was found in Staphylococcus aureus prevalence in menstrual cup users. One of the factors affecting the use of menstrual hygiene products is economic reasons. Although menstrual cups are expensive when first purchased compared to disposable products, they provide advantages in terms of both cost and solid waste within approximately 6 months of use. During the menstrual period, women may experience problems with mood, body temperature, respiration, autonomic nervous system and sleep regulation due to the effects of reproductive hormones. Sleep problems usually increase in the few days before menstruation and in the first days of menstruation. The cause of sleep problems during the menstrual period may be menstrual period symptoms, menstrual cycle characteristics, or individual-specific reasons. There are limited studies evaluating the menstrual life and sleep quality of women during the menstrual period. Studies conducted focus more on the effects of menstrual symptoms on quality of life. No randomized controlled study has been found examining the effects of menstrual cup use on quality of life and sleep. This study aimed to examine the effects of menstrual cup use on menstrual life and quality of sleep.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial, there are two groups: menstrual cup users and menstrual pad users
| Arm | Type | Receives |
|---|---|---|
| Menstrual cup users | Active comparator | Other: Using menstrual cupWomen who will use menstrual cups will be trained on the use of the product and a menstrual cup will be provided for them to use. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual cup use by sharing an online form. |
| Menstrual pad users | Active comparator | Other: Using menstrual padsFor women in the group who will use menstrual pads, the average number of pads they have used in their previous menstrual cycles will be asked and an appropriate number of menstrual pads will be provided. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual pad use by sharing an online form. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being between the ages of 18-45,
- Having a regular menstrual cycle between 21-35 days,
- Not having a sexually transmitted disease that has been diagnosed and treated,
- Not having a silicone allergy,
- Not using an intrauterine device,
Key exclusion criteria (3 listed)
- Those planning to get pregnant,
- Those with a history of sexually transmitted diseases in the last 6 months,
- Those with dysmenorrhea problems will not be included.
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 |
|---|---|---|
| Using menstrual cupIn the prospective, randomized controlled study, two groups (Case = Menstrual cup, Control = Menstrual pad) will be randomly formed from individuals who volunteer to participate in the study and meet the inclusion criteria. All participants will be asked to answer the questions in the first interview questionnaire. Women who will use menstrual cups will be trained on the use of the product and a menstrual cup will be provided for them to use. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual cup use by sharing an online form. | Other | Menstrual cup users |
| Using menstrual padsIn the prospective, randomized controlled study, two groups (Case = Menstrual cup, Control = Menstrual pad) will be randomly formed from individuals who volunteer to participate in the study and meet the inclusion criteria. All participants will be asked to answer the questions in the first interview questionnaire. For women in the group who will use menstrual pads, the average number of pads they have used in their previous menstrual cycles will be asked and an appropriate number of menstrual pads will be provided. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd, and 6th menstrual cycles and asked to answer questions about their menstrual pad use by sharing an online form. | Other | Menstrual pad users |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: The scale will be used at the end of Cycle 1, 2, 3 and 6 (each cycle is 28 days)
It was developed to evaluate sleep quality.
1 secondary outcome
Menstruation Impact Scale
Time frame: The scale will be used at the end of Cycle 1, 2, 3 and 6 (each cycle is 28 days)
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 21 May 2025.
- Individual participant dataSharing planned: No. The study data will be shared upon contact with researchers conducting meta-analysis or systematic reviews.
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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.
Zeliha Elkan Kiyat principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using menstrual cup and Using menstrual pads in people with Menstrual Cup, run by Trakya University at 1 site in Turkey (Türkiye).
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 3 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 21 May 2025. 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 Turkey (Türkiye). 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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: The scale will be used at the end of Cycle 1, 2, 3 and 6 (each cycle is 28 days)). 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 21 May 2025.